FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 800
MDR report key: 1030639
·
Received April 15, 2008
Report
- Report Number
- 1823260-2008-03231
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 24, 2008
- Report Date
- April 15, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
ONE PT SAMPLE WITH DISCREPANT LITHIUM RESULTS. INITIAL RESULT GAVE 2.68 MMOL/L. SAME SAMPLE REPEATED FIVE TIMES GIVING 0.87, 0.86 THREE TIMES AND 0.85 MMOL/L, RESPECTIVELY. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE THE CAUSE FOR THE DISCREPANCY, HOWEVER NOTED ADJUSTMENTS WERE PERFORMED ON THE ISE MIX TOWER. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS INTEGRA 800 | CLINICAL CHEMISTRY ANALYZER -JJE | JJE | ROCHE DIAGNOSTICS | I800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |