MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 02G23-25

Device Problem False Negative Result (1225)

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

Event Date 11/18/2020

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 is included.Additional patient details are not available.

Event Description

The customer reported a false negative architect (b)(6) qualitative ii confirmatory ((b)(6)) result for a (b)(6) year old female patient with known liver disease.The customer performed the neutralization confirmatory testing on a sample whose result was a reactive (b)(6).The customer provided: on (b)(6) 2020 the (b)(6) c2 initial = 0.54 s/co; on (b)(6) 2020 results: (b)(6) c1 initial = 0.26 s/co, repeat = 0.26 s/co; (b)(6) c2 initial = 0.76 s/co, repeat 0.65 s/co.The customer believes the second repeat hbsagq2 c2 to be a false negative per the patient¿s initial (b)(6) confirmatory test results, and the patient¿s clinical symptoms.There was no reported impact to patient management.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation for potential false negative results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review and device history record review.Trending review determined no adverse trend for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances or deviations with the likely cause lot.In-house testing of the reagent lot was completed; all specifications were met indicating that the lot is performing acceptably.Return testing was not completed as the sample was not available for return.Based on the investigation, no systemic issue or deficiency of the architect hbsag qualitative ii confirmatory reagent lot 12188fn00 was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY 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 4; EI F91VY4
• MDR Report Key: 10958346
• MDR Text Key: 249661747
• Report Number: 3008344661-2020-00131
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: P110029
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Catalogue Number: 02G23-25
• Device Lot Number: 12188FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)
• Patient Age: 23 YR