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 2017-03-20 for ARCHITECT AFP 03P36-26 manufactured by Abbott Ireland.
[70412199]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[70412200]
The customer observed a falsely elevated afp result for one patient while using the architect afp assay. The customer provided the following data (unit of measure not provided): initial result: about 200, retest result: 2-3. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[75436216]
Further investigation of the customer issue included a review of the complaint text, trouble shooting of the analyzer, a search for similar complaints, and a review of labeling. Return material was not available. Review of the analyzer was completed and did not identify any issues. A trending review did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information a deficiency of the architect afp reagent, list 03p36-26, was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008344661-2017-00022 |
| MDR Report Key | 6417501 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-20 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-03-20 |
| 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 | 2017-03-20 |
| Catalog Number | 03P36-26 |
| Lot Number | UNKNOWN |
| 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 | 2017-03-20 |