COBAS 8000 E 801 MODULE Adverse Event — Malfunction (MDR 1823260-2020-90079)
COBAS 8000 E 801 MODULE Adverse Event — Malfunction (MDR 1823260-2020-90079) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS 8000 E 801 MODULE; Generic name: IMMUNOCHEMISTRY ANALYZER; Manufacturer: ROCHE DIAGNOSTICS.
| Device | COBAS 8000 E 801 MODULE |
|---|---|
| Generic name | IMMUNOCHEMISTRY ANALYZER |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2020-90079 |
| Event type | Malfunction |
| Product problem | N |
| Date received | 2020-04-28 |
| Narrative | FOR 2 EVENTS, THE SERVICE ACTIONS RESOLVED THE ISSUE. FOR 2 EVENTS, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOW UP ACTION FOR 1 EVENT WAS THAT THE FIELD SERVICE REPRESENTATIVE FOUND A CLOGGED SAMPLE PROBE. HE FOUND THE SIPPER NOZZLE WAS BROKEN AND IT WAS REPLACED. THE FOLLOW UP ACTION FOR 1 EVENT WAS THAT THE FIELD SERVICE REPRES |
| Source | openFDA MAUDE (device adverse events) |
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