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 2017-10-17 for ARCHITECT TOTAL PSA 07K70-25 manufactured by Abbott Ireland.
[90551010]
This report is being filed on an international product, architect total psa, list 7k70, that has a similar product distributed in the us, architect total psa, list number 6c06. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Event problem and evaluation codes: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90551011]
The customer reported a patient received a pet scan and radiation therapy due to an elevated architect total psa result. The patient was tested on (b)(6) 2015 on the architect total psa assay as a part of routine follow up for a prostate removal which occurred in 2014. The architect generated a prostate-specific antigen (psa) result of 0. 3 ug/l (sample (b)(6)). The patient was referred to radiation oncology at a private hospital and a pet scan was performed on (b)(6) 2015 which was inconclusive. Due to the inconclusive imaging and the psa result, a course of radiotherapy was commenced at the private hospital on (b)(6) 2015. A baseline psa was taken at the private hospital on the first day of radiotherapy. At a follow up appointment with the radiation oncologist following approximately 5 treatments, the baseline psa result was noted to be <0. 01 ug/l on the roche assay. On (b)(6) the psa was repeated on the roche assay generating a result of <0. 01 ug/l and the unnecessary radiotherapy was discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2017-00091 |
| MDR Report Key | 6954707 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-05-03 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2014-11-21 |
| Date Added to Maude | 2017-10-17 |
| 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 | 2017-10-17 |
| Catalog Number | 07K70-25 |
| Lot Number | 47139LF00 |
| Device Expiration Date | 2015-11-14 |
| 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 | 1. Other | 2017-10-17 |