MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG

Catalog Number 06C36-44

Device Problem False Negative Result (1225)

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

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information patient identifier = (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This event is being filed on an international product, list 6c36, that has a similar us product, list 4p53.

Event Description

The customer reported (b)(6) alinity i hbsag results for one patient.The customer provided: sid (b)(6) hbsag = ((b)(6)); hbsab = ((b)(6)), hbeag = ((b)(6)), hbeab = ((b)(6)), hbcab = ((b)(6)); (b)(6)-dna = ((b)(6)).There was no impact to patient management reported.

Manufacturer Narrative

Product code from incorrect ksj to the correct lom.The complaint investigation for potential false negative hbsag results included a search for similar complaints, and review of complaint text, instrument result logs, trending data, labeling, and device history records.In house sensitivity testing of panels which mimic patient samples was completed using a retained kit of lot 06418fn00.All specifications were met indicating that the lot is performing acceptably.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 06418fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect hbsag assay, lot number 06418fn00 was identified.

• Brand Name: ARCHITECT HBSAG
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10044111
• MDR Text Key: 191248915
• Report Number: 3008344661-2020-00035
• 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: 06/19/2020

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: 08/27/2020
• Device Catalogue Number: 06C36-44
• Device Lot Number: 06418FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(6) ; SERIAL # (B)(6)