ARCHITECT C16000 SYSTEM Adverse Event — Malfunction (MDR 3016438761-2020-00053)
ARCHITECT C16000 SYSTEM Adverse Event — Malfunction (MDR 3016438761-2020-00053) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARCHITECT C16000 SYSTEM; Generic name: AUTOMATED CHEMISTRY ANALYZER; Manufacturer: ABBOTT LABORATORIES (IRVING IA/CC).
| Device | ARCHITECT C16000 SYSTEM |
|---|---|
| Generic name | AUTOMATED CHEMISTRY ANALYZER |
| Manufacturer | ABBOTT LABORATORIES (IRVING IA/CC) |
| Report number | 3016438761-2020-00053 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND CLEANED THE REAGENT PROBES R1 AND R2. THE BOTH REAGENT PROBES WERE DETERMINED TO BE THE LIKELY CAUSE. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS SINCE THE PROBE WAS CLEANED BY SERVICE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A 12-MONTH REVIEW OF TICKETS DID NOT IDENTIFY ANY TRENDS FOR THE |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →