MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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 Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a falsely elevated architect afp result on a (b)(6) year-old female patient.The following data was provided: initial result, on (b)(6) 2020, was 11 ng/ml, a few days later, it was repeated at another hospital with a result of about 4 (unknown unit of measure).It is unknown on what platform the repeat result was generated.It is unknown if the patient is pregnant.There was no impact to patient management.

Manufacturer Narrative

The complaint investigation for falsely elevated architect afp results included a search for similar complaints, review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Using worldwide field data, the performance of reagent lot 08069fn00 and associated sublots manufactured with the same material were evaluated and are performing similar to other reagent lots in the field confirming there was no systemic issue.Trending review determined no adverse trend for the issue for the product.Device history record review on lot 08069fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.All specifications were met indicating that the lot is performing acceptably.Based on the information provided and abbott diagnostics' complaint investigation, no systemic issue or deficiency of the architect afp assay, lot number 08069fn00, was identified.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10181729
• MDR Text Key: 225941545
• Report Number: 3008344661-2020-00051
• 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: 07/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Catalogue Number: 03P36-30
• Device Lot Number: 08069FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000 PROCESSING MODULE,; ARCHITECT I2000 PROCESSING MODULE,; LIST# 03M74-01, SERIAL# (B)(6) ; LIST# 03M74-01, SERIAL# (B)(6)
• Patient Age: 53 YR