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

Catalog Number 08P11-22

Device Problem False Positive Result (1227)

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

Event Date 11/11/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false reactive alinity i hbsag confirmatory result for one patient.The following data was provided: sid (b)(6).Hbsag initial result 2.78 and repeat results 2.31 and 2.50, confirmation test: c2 2.43, c1 0.16, neut 102% anti-hbc igm 0.10 s/co anti-hbc 0.10 s/co anti-hbs 2.14 miu/ml hbeag 0.675 s/co.The original sample and an aliquot were tested again.Both samples returned a negative result (0.24 and 0.30).No impact to patient management was reported.

Manufacturer Narrative

Information provided by the customer was reviewed.The lot search reviews did not identify an increase in complaint activity for the issue under review.Return testing was not performed as returns were not available.Device history record review was performed on lot 51569fn00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.Clinical specificity testing of alinity i hbsag qualitative ii confirmatory reagent 08p11, lot 51569fn00, was performed using retained kits.Testing met all acceptance criteria indicating the products are performing as expected and there is no issue with the lots.In this case sample and/or reagent integrity issues at the time of testing could have contributed to the customer¿s observation.Based on the investigation, no systemic issue or deficiency of the alinity i hbsag qualitative ii confirmatory assay was identified.

• Brand Name: ALINITY I 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 DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18465824
• MDR Text Key: 332326696
• Report Number: 3008344661-2024-00004
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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: 06/02/2024
• Device Catalogue Number: 08P11-22
• Device Lot Number: 51569FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)