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

Catalog Number 08P10-32

Device Problem False Positive Result (1227)

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

Event Date 11/11/2023

Event Type  malfunction  

Event Description

The customer observed a false reactive alinity i hbsag 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

Complete information from section a1 patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

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 53621fn00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.Customer field data was used to assess the performance of the alinity i hbsag assay lot 53621fn00, using worldwide data through abbottlink.The patient median result for the lot are comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Alinity i hbsag 8p10 is a highly sensitive assay which might be susceptible to interfering substances that might trigger positive assay readings.Per product labelling for the alinity i hbsag qualitative ii, for diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic infection.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 assay was identified.

• Brand Name: ALINITY I HBSAG QUALITATIVE II 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: 18301573
• MDR Text Key: 330173087
• Report Number: 3008344661-2023-00197
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08P10-32
• Device Lot Number: 53621FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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, AI22886; ALNTY I PROCESSING MODU, 03R65-01, AI22886