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 2017-04-25 for ARCHITECT AFP 03P36-26 manufactured by Abbott Ireland.
[74014807]
The customer observed a single false elevated afp results using architect afp, list 3p36-25 ((b)(4) list number 3p36-26), lot 54021lh00. The ticket searches determined normal complaint lot and no trend for the issue for the product. Historical performance of lot 54021lh00 was evaluated using world wide data from abbott link. The patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for this lot is within the established control limits and no unusual reagent lot performance was identified. A review of the manufacturing documentation for the lot did not identify any issues associated with the customer observation. A review of labeling concluded that the issue is sufficiently addressed. A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, a systemic issue and/or product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
[74014808]
The customer stated that the architect analyzer generated a falsely elevated afp result on one patient after surgery. The results provided were: (b)(6) 2016 = 18ng/ml / previously (unknown date) 5. 0ng/ml / (b)(6) 2016 = 5. 6ng/ml. There was no additional patient information provided. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2017-00037 |
| MDR Report Key | 6519924 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-25 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2015-08-06 |
| Date Added to Maude | 2017-04-25 |
| 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 AFP |
| Generic Name | ALPHA-FETOPROTEIN |
| Product Code | LOK |
| Date Received | 2017-04-25 |
| Catalog Number | 03P36-26 |
| Lot Number | 54021LH00 |
| Device Expiration Date | 2016-07-16 |
| 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 | 2017-04-25 |