MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number 06P06-60

Device Problem False Positive Result (1227)

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

Event Date 11/28/2022

Event Type  Injury  

Event Description

The customer observed false reactive alinity s anti-hbc results for one cadaveric tissue donor sample that was nat negative.The following data was provided: (b)(6) 2022 sid (b)(6) initial anti-hbc result = 6.70 s/co, repeats = 8.55 s/co and 8.04 s/co, hemolysis was 50 mg/dl.The tissue donation was rejected and not collected or discarded.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.

Manufacturer Narrative

The complaint investigation for false reactive alinity s anti-hbc 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 37332be00 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Mid america transplant svc (mats) returned a total of one cadaveric sample to abbott for the alinity s anti-hcv investigation.To assess the level of hemolysis, a visual inspection of the returned cadaveric sample 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.(b)(6): 0.9% of hemolysis, hemoglobin = 37 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%.The sample exceed the acceptable level of hemolysis per the american and european red cross standards.The sample did not exceed the package insert hemoglobin levels of less than 500 mg/dl.A technical review of field data for alinity s anti-hbc was performed.Overall reactive rates of lot 37332be00 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 37332be00 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 37332be00 is within package insert representative data for cadaveric specimens and the ir-rr rates for lot 37332be00 are lower as compared to peer sites.The alinity s anti-hbc specificity is known to be lower when compared to other assays.This is the result of higher prevalence of hepatitis b observed within some populations.Therefore, the peer data for anti-hbc lot 37332be00 is being used for relative comparison only.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 anti-hbc reagent lot 37332be00 is performing as intended, no systemic issue or deficiency of alinity s anti-hbc reagent was identified.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Type of Device: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15960035
• MDR Text Key: 305269694
• Report Number: 3002809144-2022-00432
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117207
• UDI-Public: 00380740117207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL125681
• 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: 04/19/2023
• Device Catalogue Number: 06P06-60
• Device Lot Number: 37332BE00
• 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: 02/17/2022
• 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