MAUDE Adverse Event Report: ABBOTT IRELAND 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 11/27/2022

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Mfr 3008344661-2022-00183-00 is for sid (b)(6).Mfr 3008344661-2022-00184-00 is for sid (b)(6).

Event Description

The customer observed false reactive alinity s hbsag for two cadaveric tissue donor samples that were nat negative.The following data was provided: (b)(6)2022 sid (b)(6) initial hbsag result = 1.66 s/co, repeats = 1.31 s/co and 1.36 s/co, hemolysis was 500 mg/dl.(b)(6) 2022 sid (b)(6) initial hbsag result = 2.51 s/co, repeats = 2.16 s/co and 2.25 s/co, hemolysis was 1000 mg/dl.The tissue donation was rejected and not collected or discarded.No additional impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false reactive alinity s hbsag results 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.Additionally, return sample testing was completed.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with lot 39121fn00 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Mid america transplant svc (mats) returned a total of two cadaveric samples to abbott for the alinity s hbsag investigation.To assess the level of hemolysis, a visual inspection of the returned cadaveric samples was performed.The assessment was performed by applying the visual inspection reference guide of the american red cross biomedical services.Additionally, cell-dyn sapphire hemoglobin and alinity s hbsag testing was performed.22332012a: 2% of hemolysis, hbsag results = 2.45 s/co, 2.41 s/co, and 2.25 s/co, hemoglobin = 782 mg/dl 22331034a: 2% of hemolysis, hbsag results = 1.07 s/co, 0.91 s/co, and 0.89 s/co, hemoglobin = 290 mg/dl per the american and european red cross standards, the acceptable level of hemolysis (based on visual/qualitative inspection) is less than 0.8%.Both samples exceed the acceptable level of hemolysis per the american and european red cross standards.Of the 2 alinity s hbsag tested samples, 1 was reactive with hemoglobin levels exceeding package insert and 1 was nonreactive with hemoglobin levels less than 500 mg/dl.A technical review of field data for alinity s hbsag was performed.Overall reactive rates of lot 39121fn00 across mats, applicable peer sites and across all us customer sites were collected and assessed.Across all us customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 39121fn00 are within product requirements, within package insert representative data or cadaveric specimens and comparable to other lots analyzed in the comparison.At mats the performance of lot 39121fn00 is within package insert representative data for cadaveric specimens.Based on the information within the complaint record, the devices met performance specifications at the customer site as all reactive rates were within product requirements respectively package insert representative data for cadaveric testing.Based on the investigation alinity s hbsag reagent lot 39121fn00 is performing as intended, no systemic issue or deficiency of alinity s hbsag reagent was identified.Mfr 3008344661-2022-00183-00 is for sid (b)(6).Mfr 3008344661-2022-00184-00 is for sid (b)(6).

• 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; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15960214
• MDR Text Key: 305272658
• Report Number: 3008344661-2022-00183
• 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: 02/08/2023

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: 03/19/2023
• Device Catalogue Number: 06P02-60
• Device Lot Number: 39121FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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, AS1290; ALNTY S SYSTEM, 06P16-01, AS1290
• Patient Outcome(s): Disability