COULTER LH 750 HEMATOLOGY ANALYZER
Report
- Report Number
- 1061932-2011-00641
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- December 9, 2008
- Report Date
- December 9, 2008
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K061574
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES AND STORED FOR 2 HOURS AT ROOM TEMPERATURE. SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THIS INCIDENT. ALL WERE WITHIN ACCEPTABLE LIMITS. THE FIELD SERVICE ENGINEER (FSE) REPLACED SEVERAL PARTS ASSOCIATED WITH WBC PERFORMANCE ON (B)(6) 2008, INCLUDING VALVE 3, PINCH VALVE HOLDER, ACTUATOR AND TUBING, CBC LYSE PUMP. THE FSE THEN RAN 9 REPRODUCIBILITY PROCEDURES WITH NO ISSUES. THE CUSTOMER RAN SPECIMENS IN DUPLICATE AND FOUND ONE THAT RAN WITH A WBC OF 7.7 X 10 TO THE THIRD POWER CELLS/UL FOR THE FIRST ASPIRATION AND THE SECOND WBC WAS 9.1 X 10 TO THE THIRD POWER CELLS/UL FSE FLUSHED THE VENT PATHWAY AND REPLACED THE SMALL CHECK VALVE AT THE TOP OF THE WBC BATH AND THE LARGER CHECK VALVE FOR THE WBC DRAIN. FSE ALSO PRIMED THE CBC (COMPLETE BLOOD COUNT) LYSE AND REVERIFIED. FSE ADJUSTED THE WBC VOLTAGE. A SHIFT IN THE CONDUCTIVITY WAS ALSO IDENTIFIED AND ADJUSTED. FSE VERIFIED THE ANALYZER MET SPECS. THE ROOT CAUSE IS UNK, BUT MOST LIKELY RELATED TO PARTS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR WHITE BLOOD CELL (WBC) COUNT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS EVENT INVOLVED 6 PATIENTS TESTED ON THE SAME DAY, SAME WORK SHIFT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. CORRECTED TEST RESULTS WERE SENT AFTER THE SAMPLES WERE RERUN ON A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES AND STORED FOR 2 HOURS AT ROOM TEMPERATURE. SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THIS INCIDENT. ALL WERE WITHIN ACCEPTABLE LIMITS. THE FIELD SERVICE ENGINEER (FSE) REPLACED SEVERAL PARTS ASSOCIATED WITH WBC PERFORMANCE ON (B)(6) 2008, INCLUDING VALVE 3, PINCH VALVE HOLDER, ACTUATOR AND TUBING, CBC LYSE PUMP. THE FSE THEN RAN 9 REPRODUCIBILITY PROCEDURES WITH NO ISSUES. THE CUSTOMER RAN SPECIMENS IN DUPLICATE AND FOUND ONE THAT RAN WITH A WBC OF 7.7 X 10 TO THE THIRD POWER CELLS/UL FOR THE FIRST ASPIRATION AND THE SECOND WBC WAS 9.1 X 10 TO THE THIRD POWER CELLS/UL FSE FLUSHED THE VENT PATHWAY AND REPLACED THE SMALL CHECK VALVE AT THE TOP OF THE WBC BATH AND THE LARGER CHECK VALVE FOR THE WBC DRAIN. FSE ALSO PRIMED THE CBC (COMPLETE BLOOD COUNT) LYSE AND REVERIFIED. FSE ADJUSTED THE WBC VOLTAGE. A SHIFT IN THE CONDUCTIVITY WAS ALSO IDENTIFIED AND ADJUSTED. FSE VERIFIED THE ANALYZER MET SPECS. THE ROOT CAUSE IS UNK, BUT MOST LIKELY RELATED TO PARTS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR WHITE BLOOD CELL (WBC) COUNT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS EVENT INVOLVED 6 PATIENTS TESTED ON THE SAME DAY, SAME WORK SHIFT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. CORRECTED TEST RESULTS WERE SENT AFTER THE SAMPLES WERE RERUN ON A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES AND STORED FOR 2 HOURS AT ROOM TEMPERATURE. SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THIS INCIDENT. ALL WERE WITHIN ACCEPTABLE LIMITS. THE FIELD SERVICE ENGINEER (FSE) REPLACED SEVERAL PARTS ASSOCIATED WITH WBC PERFORMANCE ON (B)(6) 2008, INCLUDING VALVE 3, PINCH VALVE HOLDER, ACTUATOR AND TUBING, CBC LYSE PUMP. THE FSE THEN RAN 9 REPRODUCIBILITY PROCEDURES WITH NO ISSUES. THE CUSTOMER RAN SPECIMENS IN DUPLICATE AND FOUND ONE THAT RAN WITH A WBC OF 7.7 X 10 TO THE THIRD POWER CELLS/UL FOR THE FIRST ASPIRATION AND THE SECOND WBC WAS 9.1 X 10 TO THE THIRD POWER CELLS/UL FSE FLUSHED THE VENT PATHWAY AND REPLACED THE SMALL CHECK VALVE AT THE TOP OF THE WBC BATH AND THE LARGER CHECK VALVE FOR THE WBC DRAIN. FSE ALSO PRIMED THE CBC (COMPLETE BLOOD COUNT) LYSE AND REVERIFIED. FSE ADJUSTED THE WBC VOLTAGE. A SHIFT IN THE CONDUCTIVITY WAS ALSO IDENTIFIED AND ADJUSTED. FSE VERIFIED THE ANALYZER MET SPECS. THE ROOT CAUSE IS UNK, BUT MOST LIKELY RELATED TO PARTS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR WHITE BLOOD CELL (WBC) COUNT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS EVENT INVOLVED 6 PATIENTS TESTED ON THE SAME DAY, SAME WORK SHIFT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. CORRECTED TEST RESULTS WERE SENT AFTER THE SAMPLES WERE RERUN ON A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES AND STORED FOR 2 HOURS AT ROOM TEMPERATURE. SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THIS INCIDENT. ALL WERE WITHIN ACCEPTABLE LIMITS. THE FIELD SERVICE ENGINEER (FSE) REPLACED SEVERAL PARTS ASSOCIATED WITH WBC PERFORMANCE ON (B)(6) 2008, INCLUDING VALVE 3, PINCH VALVE HOLDER, ACTUATOR AND TUBING, CBC LYSE PUMP. THE FSE THEN RAN 9 REPRODUCIBILITY PROCEDURES WITH NO ISSUES. THE CUSTOMER RAN SPECIMENS IN DUPLICATE AND FOUND ONE THAT RAN WITH A WBC OF 7.7 X 10 TO THE THIRD POWER CELLS/UL FOR THE FIRST ASPIRATION AND THE SECOND WBC WAS 9.1 X 10 TO THE THIRD POWER CELLS/UL FSE FLUSHED THE VENT PATHWAY AND REPLACED THE SMALL CHECK VALVE AT THE TOP OF THE WBC BATH AND THE LARGER CHECK VALVE FOR THE WBC DRAIN. FSE ALSO PRIMED THE CBC (COMPLETE BLOOD COUNT) LYSE AND REVERIFIED. FSE ADJUSTED THE WBC VOLTAGE. A SHIFT IN THE CONDUCTIVITY WAS ALSO IDENTIFIED AND ADJUSTED. FSE VERIFIED THE ANALYZER MET SPECS. THE ROOT CAUSE IS UNK, BUT MOST LIKELY RELATED TO PARTS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR WHITE BLOOD CELL (WBC) COUNT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS EVENT INVOLVED 6 PATIENTS TESTED ON THE SAME DAY, SAME WORK SHIFT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. CORRECTED TEST RESULTS WERE SENT AFTER THE SAMPLES WERE RERUN ON A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES AND STORED FOR 2 HOURS AT ROOM TEMPERATURE. SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THIS INCIDENT. ALL WERE WITHIN ACCEPTABLE LIMITS. THE FIELD SERVICE ENGINEER (FSE) REPLACED SEVERAL PARTS ASSOCIATED WITH WBC PERFORMANCE ON (B)(6) 2008, INCLUDING VALVE 3, PINCH VALVE HOLDER, ACTUATOR AND TUBING, CBC LYSE PUMP. THE FSE THEN RAN 9 REPRODUCIBILITY PROCEDURES WITH NO ISSUES. THE CUSTOMER RAN SPECIMENS IN DUPLICATE AND FOUND ONE THAT RAN WITH A WBC OF 7.7 X 10 TO THE THIRD POWER CELLS/UL FOR THE FIRST ASPIRATION AND THE SECOND WBC WAS 9.1 X 10 TO THE THIRD POWER CELLS/UL FSE FLUSHED THE VENT PATHWAY AND REPLACED THE SMALL CHECK VALVE AT THE TOP OF THE WBC BATH AND THE LARGER CHECK VALVE FOR THE WBC DRAIN. FSE ALSO PRIMED THE CBC (COMPLETE BLOOD COUNT) LYSE AND REVERIFIED. FSE ADJUSTED THE WBC VOLTAGE. A SHIFT IN THE CONDUCTIVITY WAS ALSO IDENTIFIED AND ADJUSTED. FSE VERIFIED THE ANALYZER MET SPECS. THE ROOT CAUSE IS UNK, BUT MOST LIKELY RELATED TO PARTS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR WHITE BLOOD CELL (WBC) COUNT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS EVENT INVOLVED 6 PATIENTS TESTED ON THE SAME DAY, SAME WORK SHIFT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. CORRECTED TEST RESULTS WERE SENT AFTER THE SAMPLES WERE RERUN ON A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
SAMPLES WERE COLLECTED IN 5ML VACUTAINER TUBES AND STORED FOR 2 HOURS AT ROOM TEMPERATURE. SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE UNIT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EACH SHIFT AND WERE RUN BEFORE AND AFTER THIS INCIDENT. ALL WERE WITHIN ACCEPTABLE LIMITS. THE FIELD SERVICE ENGINEER (FSE) REPLACED SEVERAL PARTS ASSOCIATED WITH WBC PERFORMANCE ON (B)(6) 2008, INCLUDING VALVE 3, PINCH VALVE HOLDER, ACTUATOR AND TUBING, CBC LYSE PUMP. THE FSE THEN RAN 9 REPRODUCIBILITY PROCEDURES WITH NO ISSUES. THE CUSTOMER RAN SPECIMENS IN DUPLICATE AND FOUND ONE THAT RAN WITH A WBC OF 7.7 X 10 TO THE THIRD POWER CELLS/UL FOR THE FIRST ASPIRATION AND THE SECOND WBC WAS 9.1 X 10 TO THE THIRD POWER CELLS/UL FSE FLUSHED THE VENT PATHWAY AND REPLACED THE SMALL CHECK VALVE AT THE TOP OF THE WBC BATH AND THE LARGER CHECK VALVE FOR THE WBC DRAIN. FSE ALSO PRIMED THE CBC (COMPLETE BLOOD COUNT) LYSE AND REVERIFIED. FSE ADJUSTED THE WBC VOLTAGE. A SHIFT IN THE CONDUCTIVITY WAS ALSO IDENTIFIED AND ADJUSTED. FSE VERIFIED THE ANALYZER MET SPECS. THE ROOT CAUSE IS UNK, BUT MOST LIKELY RELATED TO PARTS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR WHITE BLOOD CELL (WBC) COUNT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS EVENT INVOLVED 6 PATIENTS TESTED ON THE SAME DAY, SAME WORK SHIFT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. CORRECTED TEST RESULTS WERE SENT AFTER THE SAMPLES WERE RERUN ON A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER LH 750 HEMATOLOGY ANALYZER | GKZ | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | |||
| 2 | 77 YR | |||
| 3 | 64 YR | |||
| 4 | 46 YR | |||
| 5 | 74 YR | |||
| 6 | 68 YR |