COBAS INTEGRA 800 Adverse Event — Malfunction (MDR 1823260-2008-01602)
COBAS INTEGRA 800 Adverse Event — Malfunction (MDR 1823260-2008-01602) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS INTEGRA 800; Generic name: CLINICAL CHEMISTRY ANALYZER - JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | COBAS INTEGRA 800 |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01602 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | ONE PT SAMPLE WITH DISCREPANT RESULTS FOR AST. INITIAL RESULT GAVE <0 U.L; REPEATED TWICE GIVING 13 AND 14 U/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATIONS. |
| Source | openFDA MAUDE (device adverse events) |
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