MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT ANTI-HBS

Catalog Number 07C18-41

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

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.This report is being filed on an international product, list number 7c18 that has a similar product distributed in the us, list number 1l82.

Event Description

The customer reported a false positive architect (b)(6) result on a (b)(6) yr old male patient.Results provided: (b)(6) = 40 miu/ml, (b)(6) = > 250 iu/ml, (b)(6) = 12.6 s/co; immunochromatography: (b)(6) = positive, (b)(6) = negative.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for potential false reactive anti-hbs results included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.In-house testing of reagent lot 06510fn00 was completed.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review on lot 06510fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In house testing of controls which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 06510fn00 was identified.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10263750
• MDR Text Key: 230623527
• Report Number: 3008344661-2020-00057
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• 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: 08/20/2020

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: 10/24/2020
• Device Catalogue Number: 07C18-41
• Device Lot Number: 06510FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER LIST 03M74-01; SERIAL (B)(6).
• Patient Age: 52 YR