COBAS INTEGRA 400 PLUS Adverse Event — Malfunction (MDR 1823260-2020-01119)
COBAS INTEGRA 400 PLUS Adverse Event — Malfunction (MDR 1823260-2020-01119) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS INTEGRA 400 PLUS; Generic name: CLINICAL CHEMISTRY ANALYZER; Manufacturer: ROCHE DIAGNOSTICS.
| Device | COBAS INTEGRA 400 PLUS |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2020-01119 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | DURING THE INVESTIGATION, THE CUSTOMER'S ISSUE COULD BE DUPLICATED. THE INVESTIGATION DETERMINED A SOFTWARE ISSUE WAS THE ROOT CAUSE. |
| Source | openFDA MAUDE (device adverse events) |
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