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 2018-10-19 for ARCHITECT TOTAL PSA 07K70-27 manufactured by Abbott Ireland.
[126107398]
Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, and field data review. Returns were not available. No adverse trend was identified for the customer issue. Device history review did not identify any issues that may have caused the customer issue. Labeling was reviewed and found to be adequate. Abbott link world wide data was used to evaluate historical product field performance. Patient data was analyzed and compared to an established control limit. The evaluation indicated that the patient median result for the complaint lot was comparable to other lots in the field between (b)(6) 2018 to (b)(6) 2018. No unusual reagent lot performance was identified. Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found. This report is being filed on an international product, list number (b)(4) that has a similar product distributed in the us, list number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126107399]
The customer observed falsely elevated results with poor dilution linearity while using architect total psa (prostate specific antigen) reagents. The following data was provided for the same patient. Initial (undiluted) greater than 100 ng/ml, diluted (1:10) greater than 100 ng/ml, diluted (1:20) 26. 8 ng/ml, diluted (1:100) 214. 24 ng/ml. Per the product package insert, specimens with values exceeding 100 ng/ml are flagged with code greater than 100. 000 and may be diluted. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00089 |
| MDR Report Key | 7986516 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-19 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2018-10-19 |
| 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 | 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 | MTF |
| Date Received | 2018-10-19 |
| Catalog Number | 07K70-27 |
| Lot Number | 84190FN00 |
| Device Expiration Date | 2019-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-19 |