ARCHITECT PROLACTIN Adverse Event — Malfunction (MDR 3005094123-2020-00094)
ARCHITECT PROLACTIN Adverse Event — Malfunction (MDR 3005094123-2020-00094) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARCHITECT PROLACTIN; Generic name: PROLACTIN; Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD.
| Device | ARCHITECT PROLACTIN |
|---|---|
| Generic name | PROLACTIN |
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Report number | 3005094123-2020-00094 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | 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 PERFORMED USING A RETAINED KIT OF LOT 07218UI00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. TO FURTHER INVESTIGATE THE CUSTOMER'S ISSUE, THE HISTORICAL PERFORMANCE OF REAGENT LOT 07218UI00 WAS |
| Source | openFDA MAUDE (device adverse events) |
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