ARCHITECT TOTAL B-HCG Adverse Event — Malfunction (MDR 3005094123-2020-00097)
ARCHITECT TOTAL B-HCG Adverse Event — Malfunction (MDR 3005094123-2020-00097) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARCHITECT TOTAL B-HCG; Generic name: B-HCG; Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD.
| Device | ARCHITECT TOTAL B-HCG |
|---|---|
| Generic name | B-HCG |
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Report number | 3005094123-2020-00097 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | COMPLAINT TRENDING REPORT REVIEW DETERMINED THAT THERE IS NO ADVERSE TREND FOR THE PRODUCT. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR THE LOT NUMBER USING SEARCH OF THE CORRECTIVE AND PREVENTATIVE ACTION DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A TESTING PROTOCOL WAS EXECUTED USING IN H |
| Source | openFDA MAUDE (device adverse events) |
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