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

Catalog Number	03P36-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8052932
• Report Number: 3008344661-2018-00092
• Device Sequence Number: 13864179
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: 03P36-30
• Device Lot Number: 88064FN00
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN ISR53937; LN 03M74-02 SN ISR53937
• Patient Age: 55 YR