MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07C18-75

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 07c18 that has a similar product distributed in the us, list number 01l82.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) architect (b)(6) results for one male patient.The initial result (b)(6) result was (b)(6) during a physical examination test.Two days later, a new blood test was taken, and the results were (b)(6).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review & device history record review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 19676fn01 and the complaint issue.A review of the labelling and literature addresses the customer¿s issue.Per product labelling, if the anti-hbs results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.In this case, negative results or lower results were obtained on retest on another instrument, indicating possible sample or reagent handling or integrity issues or instrumentation issues for the original testing.The overall specificity for the architect anti-hbs assay (determined by considering result values of = 10.00 miu/ml as reactive) was estimated to be 99.22% at the lower 95% confidence level, therefore false reactive results may at times occur.False positive results may arise as a result of sample or reagent integrity issues at time of testing and details regarding sample and reagent handling are provided within the product package insert.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs reagent lot 19676fn01 was identified.

• Brand Name: ARCHITECT ANTI-HBS REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12462773
• MDR Text Key: 271122131
• Report Number: 3008344661-2021-00167
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: 07C18-75
• Device Lot Number: 19676FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR56695; ARC I1000SR MOD, 01L86-01, I1SR56695; ARC I1000SR MOD, (B)(4)