ARCHITECT TSH Adverse Event — Malfunction (MDR 3005094123-2020-00095)
ARCHITECT TSH Adverse Event — Malfunction (MDR 3005094123-2020-00095) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARCHITECT TSH; Generic name: TSH; Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD.
| Device | ARCHITECT TSH |
|---|---|
| Generic name | TSH |
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Report number | 3005094123-2020-00095 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER 06406UI00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERF |
| Source | openFDA MAUDE (device adverse events) |
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