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 2018-10-10 for ARCHITECT TOTAL PSA 07K70-30 manufactured by Abbott Ireland.
[125464902]
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
[125464903]
The customer observed falsely depressed results while using architect total psa (prostate specific antigen) reagents. The following data was provided for the same patient. Sid (b)(6) initial 0. 83 ng/ml, repeat 0. 80, 0. 79, 0. 74 ng/ml, repeat in another laboratory 0. 71, 0. 61, 0. 83, 0. 88 ng/ml. Sid (b)(6) initial 1. 19 ng/ml, not repeated. Sid (b)(6) initial 2. 02 ng/ml, not repeated. Sid (b)(6) initial 1. 16 ng/ml, not repeated. Sid (b)(6) initial 3. 38 ng/ml, not repeated. Sid (b)(6) initial 1. 09 ng/ml, not repeated. Sid (b)(6) initial 4. 57 ng/ml, not repeated. Sid (b)(6) initial 7. 23 ng/ml, not repeated. Sid (b)(6) initial 0. 74 ng/ml, not repeated. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00085 |
| MDR Report Key | 7954341 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-20 |
| Date Added to Maude | 2018-10-10 |
| 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 | LTJ |
| Date Received | 2018-10-10 |
| Catalog Number | 07K70-30 |
| Lot Number | 85185FN00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-10-10 |