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	10/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false reactive alinity s hbsag assay on cadaveric sample and provided the following information: reference = 1.0 s/co is reactive on (b)(6) 2023, sample id (b)(6) initial result was 16.99 (reactive) and repeat results were 16.99 (reactive) & 15.64 (reactive).Nat result was negative.Tissue status: retained, mother tested negative on (b)(6) 2023 patient information: 3 day old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination occurred on (b)(6) 2023.There was no reported impact to patient management.
Additional Manufacturer Narrative
Section h3 was updated to state that device evaluation is still in processsection d4 lot# was corrected h3 other text : device evaluation is still in process.
Event or Problem Description
The customer reported false reactive alinity s hbsag assay on cadaveric sample and provided the following information: reference = 1.0 s/co is reactive.On (b)(6) 2023, sample id (b)(6) initial result was 16.99 (reactive) and repeat results were 16.99 (reactive) & 15.64 (reactive).Nat result was negative.Tissue status: retained, mother tested negative on (b)(6) 2023.Patient information: 3 day old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination occurred on (b)(6) 2023.There was no reported impact to patient management.
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, and device history record review, and field data 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 without indication for any additional issue.Device history review did not identify any potential non-conformances, non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint issue.The ticket trending review did not identify any trends.The overall performance of the alinity s hbsag reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 50489fn00 indicated the product was performing within product requirements.Labeling was reviewed and was found to address the customer reported issue.Based on the results of the investigation, alinity s hbsag reagent, lot number 50489fn00 met performance requirements and no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported false reactive alinity s hbsag assay on cadaveric sample and provided the following information: reference = 1.0 s/co is reactive on (b)(6) 2023, sample id (b)(6) initial result was 16.99 (reactive) and repeat results were 16.99 (reactive) & 15.64 (reactive).Nat result was negative.Tissue status: retained, mother tested negative on (b)(6) 2023 patient information: 3 day old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination occurred on (b)(6) 2023.There was no reported impact to patient management.

• 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: 18143029
• Report Number: 3008344661-2023-00190
• Device Sequence Number: 12760362
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: 00380740136819
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 01/04/2024

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: 03/07/2024
• Device Catalogue Number: 06P02-60
• Device Lot Number: 50489FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 12/20/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/14/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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, AS1346; ALNTY S SYSTEM, 06P16-01, AS1346; ALNTY S SYSTEM, 06P16-01, AS1346
• Patient Age: 3 DA
• Patient Sex: Male