AU680 CHEMISTRY ANALYZER Adverse Event — Malfunction (MDR 9612296-2020-00148)
AU680 CHEMISTRY ANALYZER Adverse Event — Malfunction (MDR 9612296-2020-00148) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AU680 CHEMISTRY ANALYZER; Generic name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US; Manufacturer: BECKMAN COULTER.
| Device | AU680 CHEMISTRY ANALYZER |
|---|---|
| Generic name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US |
| Manufacturer | BECKMAN COULTER |
| Report number | 9612296-2020-00148 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AU680 CHEMISTRY ANALYZER, AND IDENTIFIED THE FAILURE MODE AS A DEFECTIVE MIX MOTOR. THE FSE REPLACED THE ISE (ION-SELECTIVE ELECTROLYTE) MIX MOTOR TO RESOLVE THE ISSUE. INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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