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

Model Number	4P54-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a (b)(6) architect hbsag qualitative confirmatory results for one sample.The following data was provided: hbsag initial (neat) result = (b)(6), repeats = (b)(6)).Hbsag confirmatory results: (b)(6).A new sample was collected and sent to (b)(6)clinic for confirmation and generated (b)(6) results.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for false nonreactive architect hbsag qualitative confirmatory results included a search for similar complaints, and review of complaint text, trending data, labeling, device history records, and in-house testing.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review on lot 26157fn00 did not show any non-conformances, potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.A retained reagent kit of the complaint lot 26157fn00 was tested in a sensitivity setup.All specifications were met, indicating the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect hbsag qualitative confirmatory for reagent lot number 26157fn00 was identified.Section d4 lot no was updated from 30201fn00 to 26157fn00 section d4 expiration date was updated from 3/24/2022 to 12/12/2021 section h4 device mfg date was updated from 8/15/2021 to 05/04/2021.
Event or Problem Description
The customer observed a false nonreactive architect hbsag qualitative confirmatory results for one sample.The following data was provided: hbsag initial (neat) result = 2559 s/co, repeats = 2634 s/co and 2694.99s/c) hbsag confirmatory results: 1:500 c2 = 99.76 (33.27%), 1:20000 c2 = 3.15 (37.3588%) a new sample was collected and sent to cleveland clinic for confirmation and generated positive results.No impact to patient management was reported.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT KIT
• Common Device Name: 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12804801
• Report Number: 3008344661-2021-00201
• Device Sequence Number: 5485157
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/16/2021

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: 12/12/2021
• Device Model Number: 4P54-25
• Device Catalogue Number: 04P54-25
• Device Lot Number: 26157FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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, ISR55147; ARC I2000SR INST, 03M74-02, ISR55147
• Patient Sex: Unknown