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	08P10-21
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6) all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false reactive alinity i hbsag qualitative ii result for a patient in the dialysis unit.The following data was provided: initial result a week ago = negative, hep b vaccine administered.(b)(6)2023 same patient, new sample.Result = positive for both hep b antigen and antibody.Sample id (b)(4)initial result = reactive.Repeat in duplicate and both results = reactive.Confirmatory test performed and result = reactive.No impact to patient management was reported.
Additional 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, and in house testing of a retained reagent kit.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Clinical specificity testing was performed using an in-house retained kit of the complaint lot.All specifications were met indicating that lot 55622fn00 is performing acceptably and there is no issue with the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i hbsag qualitative ii reagent lot 55622fn00 and was identified.
Event or Problem Description
The customer observed a false reactive alinity i hbsag qualitative ii result for a patient in the dialysis unit.The following data was provided: initial result a week ago = negative, hep b vaccine administered.(b)(6) 2023 same patient, new sample.Result = positive for both hep b antigen and antibody.Sample id (b)(6) initial result = reactive.Repeat in duplicate and both results = reactive.Confirmatory test performed and result = reactive.No impact to patient management was reported.

• Brand Name: ALINITY I HBSAG QUALITATIVE II REAGENT KIT
• Common Device Name: 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: 18440583
• Report Number: 3008344661-2024-00001
• Device Sequence Number: 12518530
• Product Code: LOM
• UDI-Device Identifier: 00380740136581
• UDI-Public: 00380740136581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 08P10-21
• Device Lot Number: 55622FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINI HBSAG QUA CONF US, 08P11-21, (B)(6). ; ALINI HBSAG QUA CONF US, 08P11-21, (B)(6). ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6). ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Unknown