MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HIV AG/AB COMBO REAGENT KIT; HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES

Catalog Number	06P01-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false reactive alinity s hiv ag/ab results for one cadaveric tissue donor that was nat negative.The following data was provided: (b)(6) 2022, sid (b)(6), initial result = 4.75 s/co, repeats = 1.08 s/co and 0.94 s/co, hemolysis = 100 mg/dl to 250 mg/dl.The tissue donation was rejected and not collected or discarded.No additional impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s hiv ag/ab results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.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 37456be00.Labeling was reviewed and sufficiently addresses the customer's issue.A technical review of field data for alinity s hiv ag/ab was performed.Across all us blood screening customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 37456be00 is within product requirements, within package insert representative data for cadaveric specimens and comparable to other lots analyzed in the comparison.At mats the performance of lot 37456be00 is within package insert representative data for cadaveric specimens and the ir-rr rates are lower as compared to peer sites.Based on the information within the complaint record, the device met performance specifications at the customer site as all reactive rates were within product requirements respectively package insert claims for cadaveric testing.Based on the investigation alinity s hiv ag/ab reagent lot 37456be00 is performing as intended, no systemic issue or deficiency of alinity s hiv ag/ab reagent was identified.

• Brand Name: ALINITY S HIV AG/AB COMBO REAGENT KIT
• Common Device Name: HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES
• 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: 15996608
• Report Number: 3002809144-2022-00443
• Device Sequence Number: 5922586
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125679
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 06P01-60
• Device Lot Number: 37456BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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 Sex: Unknown