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 2018-12-03 for ARCHITECT AFP 03P36-30 manufactured by Abbott Ireland.
[129589406]
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete. This same event was reported on a second suspect medical device in manufacturer report 1628664-2018-02093.
Patient Sequence No: 1, Text Type: N, H10
[129589407]
The customer observed falsely elevated alpha 1 fetoprotein (afp) results on the archiect i2000sr analyzer. The following data was provided: initial 725. 48, repeated 9. 0 and 8. 85 ng/ml. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00097 |
| MDR Report Key | 8124642 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-03 |
| Date of Report | 2019-02-14 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-07-20 |
| Date Added to Maude | 2018-12-03 |
| 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 AFP |
| Generic Name | ALPHA-FETOPROTEIN |
| Product Code | LOK |
| Date Received | 2018-12-03 |
| Catalog Number | 03P36-30 |
| Lot Number | 89316FN00 |
| Device Expiration Date | 2019-06-12 |
| 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 | 2018-12-03 |