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

Catalog Number 03P36-30

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 (afp) results while using architect afp reagents.The following data was provided for the same patient.Initial sid (b)(6) 53.53 ng/ml.Repeat sid (b)(6) 4.19 ng/ml.The patient was being tested after a tumor surgery.No adverse 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, accuracy testing, and field data review.The product was not returned.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.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Abbott link world wide data was used to evaluate historical product field performance.Patient data 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 between may 13, 2018 and november 10, 2018.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.Section d.Suspect medical device 4.Catalog number was changed to 03p36-30 from 03p36-35.The lot number was not changed.

• 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: 8052932
• MDR Text Key: 128070260
• Report Number: 3008344661-2018-00092
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: 03P36-30
• Device Lot Number: 88064FN00
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN ISR53937; LN 03M74-02 SN ISR53937
• Patient Age: 55 YR