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 2018-02-21 for ARCHITECT TOTAL PSA 07K70-30 manufactured by Abbott Ireland.
[100909386]
This report is being filed on an international product, list 07k70 that has a similar product distributed in the us, list number 06c06. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[100909387]
The customer observed a falsely decreased total psa result while using architect total psa reagent. The customer provided the following result data: initial result: 0. 015 ug/l (incorrect). Retest results (tested using other analyzers): 8. 681 ug/l, 8. 977 ug/l and retested with aliquoted tube: 8. 627 ug/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00005 |
| MDR Report Key | 7286399 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-21 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2018-02-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT IRELAND |
| Manufacturer Street | DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK |
| 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 | ARCHITECT TOTAL PSA |
| Generic Name | TOTAL PSA |
| Product Code | LTJ |
| Date Received | 2018-02-21 |
| Catalog Number | 07K70-30 |
| Lot Number | 77123FN00 |
| Device Expiration Date | 2018-06-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT IRELAND |
| Manufacturer Address | DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK SLIGO NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |