MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN

Catalog Number 03P36-25

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated alpha-fetoprotein results while using architect afp reagents.The following data was provided.Sid (b)(6) initial 9.96 ng/ml, repeat 10.15 ng/ml.Previously, the patient results ranged from 200 to 500 ng/ml.No change to surgery or medication was reported due to the elevated values.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, instrument log review, labeling review, field data review, and accuracy testing.Returns were not available.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to the customer issue.Labeling was reviewed and found to be adequate.Abbott link world wide data was used to evaluate historical product field performance.Patient data was analyzed and compared to an established control limit.The evaluation indicated that the patient median result for the complaint lot was within the established control limits and performance was comparable to other lots in the field with other lots in the field between february 18, 2018 and august 18, 2018.No unusual reagent lot performance was identified.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.Section b5 was corrected.The description of the issue, was corrected as the customer alleged falsely depressed results and not falsely elevated results.The values did not change.

Event Description

Updated september 5, 2018.The customer observed falsely depressed results and not falsely elevated results.The values reported did not change.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 7754528
• MDR Text Key: 116251545
• Report Number: 3008344661-2018-00068
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (y/n): N
• PMA/PMN Number: P120008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2018
• Device Catalogue Number: 03P36-25
• Device Lot Number: 81397FN00
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; LN 01L86-01 SN I1SR52994; LN 01L86-01 SN I1SR52994