FDA Adverse Event
Malfunction
Summary report: N
ANALYTICAL P MODULE
MDR report key: 1140551
·
Received August 28, 2008
Report
- Report Number
- 1823260-2008-06531
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K953239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER EXPERIENCED DISCREPANT RESULTS FOR MULTIPLE ASSAYS. EXACT NUMBER OF PATIENT SAMPLES IMPACTED BY THIS ISSUE WAS NOT PROVIDED. THE FOLLOWING PATIENT EXAMPLE WAS PROVIDED. INITIAL GLUCOSE GAVE 200 MG/DL; REPEAT RESULTED WITHIN NORMAL RANGE OF 74 TO 106 MG/DL. ACTUAL REPEAT RESULT WAS NOT PROVIDED. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE PROBLEMS WITH PROBE 1 AND PROBE 5. ISSUES WITH BOTH PROBES WERE CORRECTED. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.
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 |