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

Catalog Number	03P36-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
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.Section a patient information: no further information is available.Complete entry patient identifier: (b)(6).
Event or Problem Description
The customer reported a false elevated architect afp result for a (b)(6) female gastroenterology patient.Sample id (b)(6) generated an initial result of 1869.1 ng/ml and retest of 5.1 ng/ml.The patient also had a previous history of 5.2 ng/ml.No information on the patient's diagnosis or clinical presentation was available.No impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the customers issue included a review of the complaint text, a search for similar complaints, in-house testing, review of field data, manufacturing documentation and labeling.Return testing was not completed as returns were not available.Review of complaint activity determined that there was normal complaint activity for reagent lot 96194fn00.Tracking and trending report review for the architect afp assay determined that there are no related trends.Using worldwide field data the historical performance of reagent lot 96194fn00 was evaluated and compared to the performance of all architect afp reagent lots in the field.This evaluation indicated that the patient median result for the lot was within 3sd of the established baseline.The reagent lot was further evaluated, an in-house retained kit of reagent lot 96194fn00 was used to test a panel of known concentration.All specifications were met indicating the lot was performing acceptably.Manufacturing documentation for the lot did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect afp assay was identified.

• 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: 9363346
• Report Number: 3008344661-2019-00140
• Device Sequence Number: 2166778
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/16/2020

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: 01/31/2020
• Device Catalogue Number: 03P36-35
• Device Lot Number: 96184FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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, LIST 03M74-01,; ARCHITECT I2000SR, LIST 03M74-01,; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 69 YR