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

Catalog Number	03P36-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated afp result for one patient while using the architect afp assay.The customer provided the following data for a (b)(6) female patient: initial: 725.3 ng/ml, the average of the first 2 retest results provided was 1.7 ng/ml a third retest generated a result of 1.7 ng/ml there was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, in-house testing, field data review, a search for similar complaints, batch record review, design history record (dhr) review, and a review of labeling.Return material was not available.A review of the customer provided data and a review of the instrument logs confirmed the issue observed by the customer.An accuracy testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably.An analysis utilizing customer field data was used to assess the specificity of the assay.Instrument data analytics (ida) reports for the architect afp assay were reviewed to determine if the median patient values have shifted over time.The analysis concluded that all reagent lots read patient results consistently therefore determined the reagent is performing acceptably.Tracking and trending did not identify an adverse trend or any atypical complaint activity.No issues were identified which would indicate a product deficiency from the batch record review.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information a deficiency of the architect afp reagent, list 03p36, lot 85018fn00 was not 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: 7902148
• Report Number: 3008344661-2018-00080
• Device Sequence Number: 285093
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• 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): 12/11/2018

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: 02/09/2019
• Device Catalogue Number: 03P36-25
• Device Lot Number: 85018FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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 (B)(4); LN 03M74-02, SN (B)(4)
• Patient Age: 25 YR