MAUDE Adverse Event Report: ABBOTT IRELAND 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 09/23/2022

Event Type  malfunction  

Event Description

The customer reported a false reactive alinity i hbsag qualitative ii result on a patient.Results provided: 1.19 / 1.04 s/co, hbsag qualitative ii confirmatory: c2 = 0.80 s/co, 106% neutralization; new sample = 0.77 s/co, confirmatory is non-reactive no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8p11-22 that has a similar product distributed in the us, list number 8p11-21.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i hbsag qualitative ii confirmatory lot 33519fn00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Additionally, clinical specificity of the alinity i hbsag qualitative ii confirmatory assay has been evaluated with a retained in-house kit of the same lot# 33519fn00 and met all specifications, confirming that this lot is meeting the alinity i hbsag product requirements.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the alinity i hbsag qualitative ii confirmatory (lot# 33519fn00).

• 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; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15587164
• MDR Text Key: 303259613
• Report Number: 3008344661-2022-00125
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/17/2022

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: 11/07/2022
• Device Catalogue Number: 08P11-22
• Device Lot Number: 33519FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBSAG QUAL 1200, 08P10-32, (B)(6); ALNTY I HBSAG QUAL 1200, 08P10-32, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)