FDA Adverse Event Malfunction Summary report: N

COBAS INTEGRA 800

MDR report key: 1513194 · Received October 13, 2009

Report

Report Number: 1823260-2009-07038
Event Type: Malfunction
Date Received: October 13, 2009
Date of Event: September 23, 2009
Report Date: October 13, 2009
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JGS
PMA / PMN Number: K951595
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE FIELD SERVICE REP DETERMINED THE DRY PRESSURE WAS LOW, CAUSING THE AIR FLOW VALVE TO BE ERRATIC. HE REPLACED AND ADJUSTED THE AIR FLOW NEEDLE VALVE. TO VERIFY THE ANALYZER PERFORMANCE, HE RAN CALIBRATION AND QC WITH ACCEPTABLE RESULTS.

Description of Event or Problem · 1

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 1: 127, 135. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 10

Description of Event or Problem · 10

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 10: 131, 138. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 11

Description of Event or Problem · 11

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 11 (MALE): 124, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 12

Description of Event or Problem · 12

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 12: 125, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 13

Description of Event or Problem · 13

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 13: 128, 139. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 14

Description of Event or Problem · 14

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 14 (MALE): 131, 140. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 15

Description of Event or Problem · 15

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 15: 133, 140. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 16

Description of Event or Problem · 16

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 16: 123, 133. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 17

THE FIELD SERVICE REP DETERMINED THE DRY PRESSURE WAS LOW CAUSING THE AIR FLOW VALVE TO BE ERRATIC. HE REPLACED AND ADJUSTED THE AIR FLOW NEEDLE VALVE. TO VERIFY THE ANALYZER PERFORMANCE, HE RAN CALIBRATION AND QC WITH ACCEPTABLE RESULTS.

Description of Event or Problem · 17

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 17: 126, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 18

Description of Event or Problem · 18

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 18: 131, 142. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 19

Description of Event or Problem · 19

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 19: 112, 1110, 119. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 2

Description of Event or Problem · 2

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 2: 122, 132. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 20

Description of Event or Problem · 20

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 20 (FEMALE): 126, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 21

Description of Event or Problem · 21

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 21: 124, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 22

Description of Event or Problem · 22

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 22: 125, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 23

Description of Event or Problem · 23

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 23: 121, 132. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 24

Description of Event or Problem · 24

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 24: 127, 139. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 25

Description of Event or Problem · 25

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 25: 128, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 26

Description of Event or Problem · 26

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 26: 126, 138. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 27

Description of Event or Problem · 27

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 27: 124, 134. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 28

Description of Event or Problem · 28

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 28: 122, 135. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 29

Description of Event or Problem · 29

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 29: 124, 135. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 3

Description of Event or Problem · 3

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 3: 132, 139. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 30

Description of Event or Problem · 30

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 30: 132, 144. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 31

Description of Event or Problem · 31

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 31: 127, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 32

Description of Event or Problem · 32

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 32: 125, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 33

Description of Event or Problem · 33

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 33: 122, 129. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 34

Description of Event or Problem · 34

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 34: 126, 132. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 35

Description of Event or Problem · 35

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 35: 123, 131. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 36

Description of Event or Problem · 36

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 36: 125, 138. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 37

Description of Event or Problem · 37

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 37: 123, 1316. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 38

Description of Event or Problem · 38

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 38: 123, 134. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 39

Description of Event or Problem · 39

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 39: 124, 139. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 4

Description of Event or Problem · 4

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 4: 127, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 40

Description of Event or Problem · 40

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 40: 129, 129, 141. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 41

Description of Event or Problem · 41

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 41: 129, 144, 144. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 42

Description of Event or Problem · 42

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 42: 123, 132. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 43

Description of Event or Problem · 43

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 43 (FEMALE): 124, 125, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 44

Description of Event or Problem · 44

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 44: 122, 122, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 45

Description of Event or Problem · 45

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 45: 118, 134. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 46

Description of Event or Problem · 46

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 46: 123, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 47

Description of Event or Problem · 47

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 47: 117, 118, 129. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 48

Description of Event or Problem · 48

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 48: 136, 125, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 49

Description of Event or Problem · 49

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 49: 123, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 5

Description of Event or Problem · 5

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 5: 126, 136. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 50

Description of Event or Problem · 50

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 50: 129, 143. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 51

Description of Event or Problem · 51

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 51: 128, 140. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 52

Description of Event or Problem · 52

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 52: 115, 125, 126. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 6

Description of Event or Problem · 6

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 6: 128, 140. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 7

Description of Event or Problem · 7

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 7: 131, 137. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 8

Description of Event or Problem · 8

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 8: 130, 138. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Additional Manufacturer Narrative · 9

Description of Event or Problem · 9

THE USER RECEIVED ERRONEOUS ISE RESULTS FOR MULTIPLE PT SAMPLES AND STATED SHE HAD RECEIVED CALLS FROM THE NURSING STATIONS SUSPECTING ERRONEOUS SODIUM RESULTS. THE INITIAL RESULTS WERE RUN ON THE INTEGRA 800 (B)(4) ON (B)(6) 2009 AND WERE REPEATED ON OTHER INTEGRA 800 (B)(4) ON (B)(6) 2009. ALL RESULTS ARE IN MMOL PER L. OF THE PT DATA PROVIDED, 52 RESULTS WERE DISCREPANT. PT 9: 129, 139. THE ERRONEOUS RESULTS WERE REPORTED. NO PTS WERE ADVERSELY AFFECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COBAS INTEGRA 800	CLINICAL CHEMISTRY ANALYZER - JJE	JGS	ROCHE DIAGNOSTICS	I800

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK
10	UNK
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5	UNK
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51	UNK
52	UNK
6	UNK
7	UNK
8	UNK
9	UNK

PSUR Report

Adverse event trends and recalls for this product code — ready for your PSUR.

Generate PSUR data report for JGS

Terms

Patient problem · 1

No Known Impact Or Consequence To Patient

Product problems · 1

Low Test Results

Source type · 2

Health Professional User facility

Type of report · 1

Initial submission

Seq	Age	Sex	Outcome	Treatment
1	UNK
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5	UNK
50	UNK
51	UNK
52	UNK
6	UNK
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8	UNK
9	UNK

Seq	Age	Sex	Outcome	Treatment
1	UNK
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5	UNK
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51	UNK
52	UNK
6	UNK
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9	UNK

Seq	Age	Sex	Outcome	Treatment
1	UNK
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4	UNK
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48	UNK
49	UNK
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52	UNK
6	UNK
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9	UNK