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 2016-11-18 for ARCHITECT AFP 03P36-26 manufactured by Abbott Ireland.
[60377723]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient information; patient identifier - the complete first sid is (b)(6) and the follow-up sid is (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[60377724]
The customer stated that the architect analyzer generated falsely elevated afp results on one patient. The results provided were: (b)(6) on (b)(6) 2016 = 346ng/ml / afp l3 fraction from outsource = 2. 6. The customer repeated a sample ((b)(6) on (b)(6) 2016) from the same patient /same day, different tube, and obtained 4. 7. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
[63871818]
On 02dec2016 customer support provided the lot number- lot # from unknown to 62214fn00. The customer observed a single false elevated afp result using architect afp, list 3p36-25 ((b)(4) list number 3p36-26), lot 62214fn00. No patient sample was available to assist in the investigation. A review of complaints found no trend for lot 62214fn00. Accuracy testing was performed with a file sample of lot 62214fn00 and a serum based panel sample with a target concentration of 20 ng/ml. All specifications were met indicating that lot 62214fn00 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 labeling shows adequate information is provided to address discrepant results including sample integrity / sample handling issues. The architect system operations manual provides troubleshooting for falsely elevated results. Based on all available information and this investigation, the assay performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[74922022]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008344661-2016-00072 |
| MDR Report Key | 6112860 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-11-18 |
| Date of Report | 2017-05-09 |
| Date of Event | 2016-10-24 |
| Date Mfgr Received | 2017-05-09 |
| Device Manufacturer Date | 2016-04-13 |
| Date Added to Maude | 2016-11-18 |
| 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 | 2016-11-18 |
| Catalog Number | 03P36-26 |
| Lot Number | 62214FN00 |
| Device Expiration Date | 2017-03-11 |
| 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 | 2016-11-18 |