COBAS INTEGRA 400 Adverse Event — Malfunction (MDR 1823260-2008-01607)
COBAS INTEGRA 400 Adverse Event — Malfunction (MDR 1823260-2008-01607) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS INTEGRA 400; Generic name: CLINICAL CHEMISTRY ANALYZER- JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | COBAS INTEGRA 400 |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER- JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01607 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | FOUR PTS SAMPLES WITH DISCREPANT RESULTS. PT 1, INITIAL MAGNESIUM GAVE 0.0 MG/DL; REPEAT GAVE 1.7 MG/DL. PT 2, INITIAL CREATININE GAVE 0.1 MG/DL; REPEAT GAVE 1.1 MG/DL. PROVIDED 2 OTHER PT SAMPLES STATING THAT THEY INITIALLY RESULTED AS ZERO, REPEATED NORMAL. NO TEST NAMES OR ACTUAL DATA WAS PROVIDED BY CUSTOMER FOR THESE PT SAMPLES. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTA |
| Source | openFDA MAUDE (device adverse events) |
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