FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 800
MDR report key: 1002623
·
Received February 8, 2008
Report
- Report Number
- 1823260-2008-01355
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- November 18, 2003
- Report Date
- February 8, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.
Description of Event or Problem · 1
INTERMITTENT DISCREPANT RESULTS FOR MULTIPLE PT'S FROM 2003 TO 2007. THE FOLLOWING DATA WAS PROVIDED; UNITS OF MEASURE NOT PROVIDED. TESTS INVOLVED ARE SODIUM (NA), POTASSIUM (K), BICARBONATE (CO2), CREATININE (CREAT), BUN, ALBUMIN (ALB) AND TOTAL PROTEIN (TP). EACH SAMPLE WAS REPEATED EITHER TWO, THREE OR FOUR TIMES. SEE SCANNED TABLE.
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 | UNK |