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

Catalog Number	04P53-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false reactive architect hbsag qualitative, architect ausab and architect hbsag qualitative confirmatory for one patient.The following results were provided: (b)(6) 2024, sid (b)(6), initial hbsag= reactive; repeated in duplicate= reactive; neutralizing confirmatory testing= reactive the patient sample was sent out to a reference lab on 19jul2024, hbsag came back non-reactive.There was no impact to patient management reported.
Additional Manufacturer Narrative
Update to section b5 - describe event or problem.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in-house testing of a retained reagent kit and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.The search for similar complaints for lot 61278fz00 did not identify an increase in complaint activity for the issue.The ticket trending review did not identify any trend regarding commonalities for lot number 61278fz00 and issue.A device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 61278fz00 and complaint issue.In-house specificity testing was completed with retained complaint lot number 61278fz00.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect hbsag qualitative lot 61278fz00 was identified.
Event or Problem Description
The customer observed a false reactive architect hbsag qualitative and architect hbsag qualitative confirmatory for one patient.The following results were provided: on (b)(6) 2024, sid (b)(6), initial hbsag= reactive; repeated in duplicate= reactive; neutralizing confirmatory testing= reactive.The patient sample was sent out to a reference lab on (b)(6) 2024, hbsag came back non-reactive.There was no impact to patient management reported.

• Brand Name: ARCHITECT HBSAG QUALITATIVE 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: 20048264
• Report Number: 3008344661-2024-00099
• Device Sequence Number: 12751522
• Product Code: LOM
• UDI-Device Identifier: 00380740007782
• UDI-Public: (01)00380740007782(17)241016(10)61278FZ00
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/13/2024

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: 10/06/2024
• Device Catalogue Number: 04P53-35
• Device Lot Number: 61278FZ00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown