MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-11 for ALERE DETERMINE HIV-1/2 AG/AB COMBO 7D2648 manufactured by Abbott Diagnostics Scarborough, Inc..
| Report Number | 1221359-2020-00011 |
| MDR Report Key | 9818603 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-12-18 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ERIN ROWLEY |
| Manufacturer Street | 10 SOUTHGATE ROAD |
| Manufacturer City | SCARBOROUGH, ME |
| Manufacturer Country | US |
| Manufacturer Phone | 7305858 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE DETERMINE HIV-1/2 AG/AB COMBO |
| Generic Name | IVD FOR HIV 1/2 AG/AB |
| Product Code | MZF |
| Date Received | 2020-03-11 |
| Catalog Number | 7D2648 |
| Lot Number | 115049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. |
| Manufacturer Address | 10 SOUTHGATE ROAD SCARBOROUGH, ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |