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 2017-09-11 for ARCHITECT AFP 3P36-25 03P36-25 manufactured by Abbott Ireland.
[86340759]
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
[86340760]
The customer observed falsely elevated alpha-fetoprotein (afp) results while using the architect afp reagents. The following data was provided. Initial 63. 1 ng/ml, repeat 42. 9 ng/ml. A new specimen was obtained and the result was lower, 2. 2 ng/ml. Result for this specimen in another laboratory was 1. 9 ng/ml. The patient is a child that was diagnosed with immature teratoma of the retroperitoneal space and was treated in 2015. The patient was being monitored after treatment of germogenic tumors. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2017-00080 |
| MDR Report Key | 6856406 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-11 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2017-09-11 |
| Model Number | 3P36-25 |
| Catalog Number | 03P36-25 |
| Lot Number | 70095FN00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2017-09-11 |