ISE INDIRECT K+ FOR GEN.2
Report
- Report Number
- 1823260-2011-03753
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- June 16, 2011
- Report Date
- August 31, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CEM
- PMA / PMN Number
- K060373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
FURTHER INVESTIGATION DETERMINED THE ROOT CAUSE FOR THE ISSUE COULD BE A BAD CALIBRATION. AFTER REPLACEMENT OF THE REFERENCE ELECTRODE AND RECALIBRATION, THE ISSUE APPEARED TO BE RESOLVED. AS ADDITIONAL DATA WAS NOT PROVIDED, FURTHER INVESTIGATION WAS NOT POSSIBLE.
OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORT WITH PATIENT IDENTIFIER: (B)(6).
THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE-POTASSIUM RESULTS FOR OVER 100 PATIENT SAMPLES FROM THE COBAS 8000 ISE MODULE SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR 53 PATIENT SAMPLES WERE DISCREPANT. THE REPEAT TESTING WAS PERFORMED ON A COBAS 6000 ANALYZER. ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 4.7 AND THE REPEAT RESULT WAS 5.2. PATIENT SAMPLE 2 INITIAL RESULT WAS 4.7 AND THE REPEAT RESULT WAS 5.2. PATIENT SAMPLE 3 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1. PATIENT SAMPLE 4 INITIAL RESULT WAS 5.1 AND THE REPEAT RESULT WAS 5.6. PATIENT SAMPLE 5 INITIAL RESULT WAS 4.5 AND THE REPEAT RESULT WAS 5.0. PATIENT SAMPLE 6 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1. PATIENT SAMPLE 7 INITIAL RESULT WAS 4.1 AND THE REPEAT RESULT WAS 4.6. PATIENT SAMPLE 8 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1. PATIENT SAMPLE 9 INITIAL RESULT WAS 3.8 AND THE REPEAT RESULT WAS 4.3. PATIENT SAMPLE 10 INITIAL RESULT WAS 3.8 AND THE REPEAT RESULT WAS 4.3. PATIENT SAMPLE 11 INITIAL RESULT WAS 3.5 AND THE REPEAT RESULT WAS 5.3. PATIENT SAMPLE 12 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2. PATIENT SAMPLE 13 INITIAL RESULT WAS 4.2 AND THE REPEAT RESULT WAS 4.7. PATIENT SAMPLE 14 INITIAL RESULT WAS 4.2 AND THE REPEAT RESULT WAS 4.7. PATIENT SAMPLE 15 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1. PATIENT SAMPLE 16 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.4. PATIENT SAMPLE 17 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.4. PATIENT SAMPLE 18 INITIAL RESULT WAS 5.1 AND THE REPEAT RESULT WAS 5.6. PATIENT SAMPLE 19 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2. PATIENT SAMPLE 20 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.2. PATIENT SAMPLE 21 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.4. PATIENT SAMPLE 22 INITIAL RESULT WAS 4.3 AND THE REPEAT RESULT WAS 4.8. PATIENT SAMPLE 23 INITIAL RESULT WAS 4.4 AND THE REPEAT RESULT WAS 4.9. PATIENT SAMPLE 24 INITIAL RESULT WAS 3.8 AND THE REPEAT RESULT WAS 4.3. PATIENT SAMPLE 25 INITIAL RESULT WAS 4.0 AND THE REPEAT RESULT WAS 4.5. PATIENT SAMPLE 26 INITIAL RESULT WAS 4.1 AND THE REPEAT RESULT WAS 4.6. PATIENT SAMPLE 27 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.5. PATIENT SAMPLE 28 INITIAL RESULT WAS 4.6 AND THE REPEAT RESULT WAS 5.1. PATIENT SAMPLE 29 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2. PATIENT SAMPLE 30 INITIAL RESULT WAS 4.3 AND THE REPEAT RESULT WAS 4.8. PATIENT SAMPLE 31 INITIAL RESULT WAS 3.8 AND THE REPEAT RESULT WAS 4.3. PATIENT SAMPLE 32 INITIAL RESULT WAS 5.3 AND THE REPEAT RESULT WAS 5.8. PATIENT SAMPLE 33 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2. PATIENT SAMPLE 34 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.4. PATIENT SAMPLE 35 INITIAL RESULT WAS 3.1 AND THE REPEAT RESULT WAS 3.7. PATIENT SAMPLE 36 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.5. PATIENT SAMPLE 37 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2. PATIENT SAMPLE 38 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1. PATIENT SAMPLE 39 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.3. PATIENT SAMPLE 40 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.5. PATIENT SAMPLE 41 INITIAL RESULT WAS 3.4 AND THE REPEAT RESULT WAS 4.0. PATIENT SAMPLE 42 INITIAL RESULT WAS 4.0 AND THE REPEAT RESULT WAS 4.7. PATIENT SAMPLE 43 INITIAL RESULT WAS 4.9 AND THE REPEAT RESULT WAS 5.4. PATIENT SAMPLE 44 INITIAL RESULT WAS 4.3 AND THE REPEAT RESULT WAS 4.8. PATIENT SAMPLE 45 INITIAL RESULT WAS 4.4 AND THE REPEAT RESULT WAS 4.9. PATIENT SAMPLE 46 WAS FROM A (B)(6) MALE. THE INITIAL RESULT WAS 4.7 AND THE REPEAT RESULT WAS 5.2 (5.15 WITH A DATA FLAG). PATIENT SAMPLE 47 INITIAL RESULT WAS 4.3 AND THE REPEAT RESULT WAS 4.9 (4.88). PATIENT SAMPLE 48 INITIAL RESULT WAS 4.7 AND THE REPEAT RESULT WAS 5.4 (5.36 WITH A DATA FLAG). PATIENT SAMPLE 49 INITIAL RESULT WAS 3.2 AND THE REPEAT RESULT WAS 3.8 (3.78). PATIENT SAMPLE 50 INITIAL RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1 (4.12). PATIENT SAMPLE 51 INITIAL RESULT WAS 4.2 AND THE REPEAT RESULT WAS 4.7 (4.65). PATIENT SAMPLE 52 INITIAL RESULT WAS 4.0 AND THE REPEAT RESULT WAS 4.5 (4.47). PATIENT SAMPLE 53 INITIAL RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.1 (4.11). THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED RESULTS WERE SENT FOR ABOUT 100 SAMPLES. NONE OF THE PATIENTS WERE TREATED OR ADVERSELY AFFECTED BASED ON THE ERRONEOUS RESULTS. THE PATIENT FOR SAMPLE 46 WAS INSTRUCTED TO GO TO THE ER BUT ENDED UP NOT GOING SINCE HIS GENERAL PRACTITIONER REQUESTED HE COME IN THE FOLLOWING MORNING AND BE REDRAWN. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS THE REFERENCE ELECTRODE AND REPLACED IT. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS THAT MET THE LABORATORY'S SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISE INDIRECT K+ FOR GEN.2 | ELECTRODE, ION SPECIFIC, POTASSIUM | CEM | ROCHE DIAGNOSTICS | NA | R87 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |