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	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer observed false repeat reactive alinity s hbsag results for a cadaveric tissue a donor samples that was confirmatory testing and nat negative.The results provided were: sid (b)(6) 58yrs old male: hbsag = repeat reactive (no actual results provided) /nat = negative /confirmatory testing = negative.All other hepatitis b testing nonreactive (negative) for this donor.The tissue was discarded for impacted sids.No additional 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.Complete information for section a patient information, 1.Patient identifier = sid = (b)(6).
Event or Problem Description
The customer observed false repeat reactive alinity s hbsag results for a cadaveric tissue a donor samples that was confirmatory testing and nat negative.The results provided were: sid (b)(6) 58yrs old male: hbsag= repeat reactive (no actual results provided) /nat=negative /confirmatory testing=negative.All other hepatitis b testing nonreactive (negative) for this donor.The tissue was discarded for impacted sids.No additional impact to patient management was reported.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for alinity hbsag assay, list number (ln) 6p02-60, lot 46338fn00.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.The tracking and trending report review determined that there are no trends.A review of ticket trending was performed and did not identify any trends.A review of labeling was also performed and concluded that the issue is sufficiently addressed.A technical review of field data for alinity s hbsag was also performed.The review consisted of looking at the overall reactive rates of ln 6p02-60, lot 46338fn00 across core, applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma monitoring group the performance of lots 46338fn00 is within product requirements and comparable to other lots analyzed in the comparison.Additionally, at core, the specificity performance of lots 46338fn00 is within package insert representative data for cadaveric specimens.Based on the results of the investigation, the alinity s hbsag, ln 6p02-60, lot 46338fn00, is performing as expected and the device met performance specifications at the customer site as all reactive rates were within product requirements respectively package insert representative data for cadaveric testing.Further, no systemic issue or product deficiency was identified for alinity s hbsag, reagent lot 46338fn00.

• 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: 17995533
• Report Number: 3008344661-2023-00187
• Device Sequence Number: 15141881
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Catalogue Number: 06P02-60
• Device Lot Number: 46338FN00
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 58 YR
• Patient Sex: Male