COBAS 8000 C 702 MODULE Adverse Event — Malfunction (MDR 1823260-2020-01124)
COBAS 8000 C 702 MODULE Adverse Event — Malfunction (MDR 1823260-2020-01124) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS 8000 C 702 MODULE; Generic name: CLINICAL CHEMISTRY ANALYZER; Manufacturer: ROCHE DIAGNOSTICS.
| Device | COBAS 8000 C 702 MODULE |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2020-01124 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | THIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON 16-APR-2020 AND FOUND BROKEN RINSE TUBING AND A NEEDLE WAS NOT MOVING CORRECTLY CAUSING A DECREASED LEVEL FOR THE RINSE CUVETTES. THE FSE FIXED THE BROKEN TUBE AND THE ISSUE WITH THE NEEDLE MOVEMENT AFFECTING THE RINSE LEVEL. THE SERVICE ACTIONS RESOLVED THE ISSUE. |
| Source | openFDA MAUDE (device adverse events) |
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