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

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  Injury  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 326380890
• Report Number: 3008344661-2023-00187
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: 00380740136819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL 125674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Sex: Male