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 Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a falsely elevated afp result for one patient while using the architect afp assay.The customer provided the following data: on (b)(6) 2018: initial: 10.62 ng/ml, diluted 1:2: 2.78 ng/ml, retest of non-diluted specimen: 2.88 ng/ml there was no adverse impact to patient management reported.

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.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 81397fn00 was not identified.

• 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: 7598146
• MDR Text Key: 111014770
• Report Number: 3008344661-2018-00050
• Device Sequence Number: 1
• Product Code: LOK
• 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: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01, SN (B)(4); LN 03M74-01, SN (B)(4)