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 2017-08-18 for ARCHITECT TOTAL PSA 07K70-25 manufactured by Abbott Ireland.
[83223022]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[83223023]
The customer observed a falsely depressed total psa results on the architect i1000sr analyzer. The following data was provided for one male patient: initial 1. 52 ng / ml, repeat 1. 3 ng / ml. The sample was confirmed higher on another method (eclia) 6. 05, 5. 87 ng/ml and (immulite) 5. 45. The customer suspects interference with the patients drug proscar (finasteride). A second patient had a result of 0. 07 ng/ml, repeated on eclia as 0. 30 ng/ml, no further patient details were provided. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2017-00075 |
| MDR Report Key | 6805054 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2017-01-09 |
| Date Added to Maude | 2017-08-18 |
| 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 | 2017-08-18 |
| Catalog Number | 07K70-25 |
| Lot Number | 71191FN00 |
| Device Expiration Date | 2017-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-18 |