MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY S HBSAG REAGENT KIT; ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)

Catalog Number	06P02-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false repeat reactive alinity s hbsag results on multiple donors.The following results were provided: date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.45 / 1.43 / 1.63 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.88 / 1.46 / 1.33 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.47 / 1.07 / 1.20 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.11 / 1.05 / 1.10 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.49 / 1.58 / 1.61 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.08 / 0.99 / 1.04 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.58 / 1.66 / 1.66 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.81 / 2.11 / 2.34 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.53 / 1.18 / 1.23 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.5 / 1.61 / 1.87 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.05 / 1.09 / 0.93 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.19 / 1.37 / 1.46 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.8 / 1.68 / 1.63 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.53 / 1.27 / 1.06 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.37 / 1.21 / 1.27 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.28 / 1.12 / 1.06 s/co; nat result: negative date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.95 / 1.60 / 1.60 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.64 / 1.49 / 1.40 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.24 / 1.22 / 1.23 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 2.21 / 1.29 / 1.08 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.65 / 1.96 / 1.62 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.05 / 1.08 / 1.03 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.15 / 1.41 / 1.40 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.15 / 1.06 / 1.09 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.79 / 1.73 / 1.49 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.24/ 1.01/ 1.00 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.02/ 1.03/ 0.85 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.47/ 1.40/ 1.41 s/co; nat result: negative.Date: (b)(6) 2023; assay: hbsag; sid: (b)(6); alinity results: = 1.97/ 1.64/ 1.54 s/co; nat result: negative.No impact to donor management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier sids: (b)(6).
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause alinity s hbsag reagent lot 49618fn00 identified normal complaint activity.Field data review showed that the repeat reactive rate observed for the complaint lot in blood banks meets the specificity performance claim of the package insert.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.No customer returns were available for evaluation.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lots.This review did not identify any non-conformances, potential non-conformances, or deviations.A review of labeling concluded that the issue is sufficiently addressed.No systemic issue and/or product deficiency was identified.
Event or Problem Description
The customer reported false repeat reactive alinity s hbsag results on multiple donors.The following results were provided: date assay sid alinity results nat result 9/6/2023 hbsag (b)(6) = 1.45 / 1.43 / 1.63 s/co negative.9/6/2023 hbsag (b)(6) = 1.88 / 1.46 / 1.33 s/co negative.9/7/2023 hbsag (b)(6) = 1.47 / 1.07 / 1.20 s/co negative.9/7/2023 hbsag (b)(6) = 1.11 / 1.05 / 1.10 s/co negative.9/8/2023 hbsag (b)(6) = 1.49 / 1.58 / 1.61 s/co negative.9/8/2023 hbsag (b)(6) = 1.08 / 0.99 / 1.04 s/co negative.9/8/2023 hbsag (b)(6) = 1.58 / 1.66 / 1.66 s/co negative.9/9/2023 hbsag (b)(6) = 1.81 / 2.11 / 2.34 s/co negative.9/9/2023 hbsag (b)(6) = 1.53 / 1.18 / 1.23 s/co negative.9/9/2023 hbsag (b)(6) = 1.5 / 1.61 / 1.87 s/co negative.9/9/2023 hbsag (b)(6) = 1.05 / 1.09 / 0.93 s/co negative.9/9/2023 hbsag (b)(6) = 1.19 / 1.37 / 1.46 s/co negative.9/9/2023 hbsag (b)(6) = 1.8 / 1.68 / 1.63 s/co negative.9/10/2023 hbsag (b)(6) = 1.53 / 1.27 / 1.06 s/co negative.9/10/2023 hbsag (b)(6) = 1.37 / 1.21 / 1.27 s/co negative.9/10/2023 hbsag (b)(6) = 1.28 / 1.12 / 1.06 s/co negative.9/10/2023 hbsag (b)(6) = 1.95 / 1.60 / 1.60 s/co negative.9/11/2023 hbsag (b)(6) = 1.64 / 1.49 / 1.40 s/co negative.9/12/2023 hbsag (b)(6) = 1.24 / 1.22 / 1.23 s/co negative.9/12/2023 hbsag (b)(6) = 2.21 / 1.29 / 1.08 s/co negative.9/12/2023 hbsag (b)(6) = 1.65 / 1.96 / 1.62 s/co negative.9/12/2023 hbsag (b)(6) = 1.05 / 1.08 / 1.03 s/co negative.9/12/2023 hbsag (b)(6) = 1.15 / 1.41 / 1.40 s/co negative.9/12/2023 hbsag (b)(6) = 1.15 / 1.06 / 1.09 s/co negative.9/13/2023 hbsag (b)(6) = 1.79 / 1.73 / 1.49 s/co negative.9/14/2023 hbsag (b)(6) = 1.24/ 1.01/ 1.00 s/co negative.9/14/2023 hbsag (b)(6) = 1.02/ 1.03/ 0.85 s/co negative.9/15/2023 hbsag (b)(6) = 1.47/ 1.40/ 1.41 s/co negative.9/15/2023 hbsag (b)(6) = 1.97/ 1.64/ 1.54 s/co negative.No impact to donor management was reported.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Common Device Name: ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND 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: 17949976
• Report Number: 3008344661-2023-00183
• Device Sequence Number: 7754545
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: 00380740136819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125674
• 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): 11/21/2023

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: 02/14/2024
• Device Catalogue Number: 06P02-60
• Device Lot Number: 49618FN00
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: ALNTY S SYSTEM, 06P16-01, AS1413; ALNTY S SYSTEM, 06P16-01, AS1413
• Patient Sex: Unknown