MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-11 for ALINITY I TOTAL PSA REAGENT KIT 07P92-30 manufactured by Abbott Ireland Diagnostics Division.
| Report Number | 3008344661-2020-00014 |
| MDR Report Key | 9695211 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT IRELAND DIAGNOSTICS DIVISION |
| Manufacturer Street | FINISKLIN BUSINESS PARK DIAGNOSTICS DIVISION |
| Manufacturer City | SLIGO NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINITY I TOTAL PSA REAGENT KIT |
| Generic Name | PROSTATIC SPECIFIC ANTIGEN (PSA) |
| Product Code | MTF |
| Date Received | 2020-02-11 |
| Catalog Number | 07P92-30 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION |
| Manufacturer Address | FINISKLIN BUSINESS PARK DIAGNOSTICS DIVISION SLIGO NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |