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 2018-08-30 for ARCHITECT TOTAL PSA 07K70-27 manufactured by Abbott Ireland.
[118887130]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 7k70 that has a similar product distributed in the us, list number 6c06. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[118887131]
The customer observed falsely elevated results while using architect total psa (prostate specific antigen) reagents. The following data was provided. The customer stated the initial results were obtained before the controls were out of range and calibration failure was observed and repeat values were obtained after calibration passed. Sid (b)(6) initial 0. 48 ng/ml, repeat 0. 00 ng/ml. Sid (b)(6) initial 0. 53 ng/ml, repeat 0. 01 ng/ml. Sid (b)(6) initial 0. 54 ng/ml, repeat 0. 00 ng/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00073 |
| MDR Report Key | 7835205 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-30 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-08-30 |
| 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 | 2018-08-30 |
| Catalog Number | 07K70-27 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-08-30 |