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 2017-01-16 for ARCHITECT AFP 03P36-30 manufactured by Abbott Ireland.
[64917064]
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
[64917125]
The customer stated that the architect analyzer generated falsely elevated afp results on one patient. The results provided were: initial 993. 96 / repeated = 3. 21. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
[73009839]
The customer observed a single false elevated afp result using architect afp, list 3p36-30, lot 64393fn00. No patient sample was available to assist in the investigation. The complaint text states that the customer measured afp for a patient who was not diagnosed with testicular cancer or was at 15 to 21 weeks gestation. The information provided indicates that the afp assay was used for screening which was not in alignment with the afp assay labeling. Historical performance of list 3p36 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 lot 64393fn00 is within the established control limits and no unusual reagent lot performance was identified. No adverse trend was identified for the customer's issue. A review of complaints determined that there is no unusual complaint activity for lot 64393fn00. Accuracy testing was performed with a file sample of lot 64393fn00 and a serum based panel sample and all specifications were met indicating that lot 64393fn00 is performing acceptably. A review of the manufacturing records for this lot did not identify any issues associated with the customer observation. A review of assay labeling and the architect operations manual shows adequate information is provided to address discrepant results including sample integrity/ sample handling issues. Based on the investigation no product deficiency was identified. A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008344661-2017-00004 |
| MDR Report Key | 6253088 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-16 |
| Date of Report | 2017-04-03 |
| Date of Event | 2016-12-22 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2016-06-16 |
| Date Added to Maude | 2017-01-16 |
| 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 | 2017-01-16 |
| Catalog Number | 03P36-30 |
| Lot Number | 64393FN00 |
| Device Expiration Date | 2017-05-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-01-16 |