FDA Adverse Event
Malfunction
Summary report: N
ANALYTICAL P MODULE
MDR report key: 1053007
·
Received May 27, 2008
Report
- Report Number
- 1823260-2008-04305
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- May 7, 2008
- Report Date
- May 27, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
TWO PATIENT SAMPLES WITH DISCREPANT RESULTS FOR BICARBONATE (CO2), AND CREATININE. PT 1, INITIAL CO2 RESULT GAVE 65 MMOL/L; REPEAT GAVE 33 MMOL/L. PATIENT 2, INITIAL CREATININE GAVE 2.4 MG/DL; REPEAT GAVE 1.1 MG/DL. ERRONEOUS RESULT WAS REPORTED FOR PATIENT 2 ONLY. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE CAUSE FOR THE DISCREPANCY WAS DUE TO A BROKEN VACUUM CONNECTOR ON RINSE MECHANISM, AND REPLACED NOZZLE C ASSEMBLY AND BLEACHED OUT CUVETTE WASH FILL LINES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANALYTICAL P MODULE | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | P MODULE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |