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	10/20/2022
Type of Reportable Event	Malfunction
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 repeat reactive alinity s hiv ag/ab combo results for one sample from a 42-year-old female donor patient.Sid (b)(6) generated an initial result of 1.82 s/co, repeated 1.73 s/co and 1.82 s/co, sample was normal in appearance, no hemolysis or lipemia.The sample was nat negative.Sample sent for western blot by third party, results not available.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Additional patient results were added on 23nov2022.The customer reported two additional samples with false repeat reactive alinity s hiv ag/ab combo results.Sid (b)(6) 23-year-old male, initial result 3.08, repeats 2.88 and 3.11 s/co; sid (b)(6) 13-year-old male, initial result 2.59, repeats 3.03 and 3.05 s/co.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.H3 other text : device evaluation is in process.
Additional Manufacturer Narrative
Evaluation of complaint data for the product did not identify an increase in complaint activity for the complaint issue.Return testing was not performed as returns were not available.Device history record review was performed on lot 37456be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.A technical review of field data for alinity s hiv ag/ab combo was performed.Overall reactive rates of ln 6p01-60, lot 37456be00 across core, applicable peer sites and across all us customer sites were collected and assessed.Since transplant samples are from potential organ donors at the end of life, the attributes of the samples are different from normal healthy routine blood donors.As a result, transplant customer performance is compared to representative cadaveric data as stated in the package insert of the applicable assay for cadaveric specimen.The peer group for this evaluation are the other us transplant sites, based on the unique impact of testing cadaveric samples.Across all us 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 and comparable to other lots analyzed in the comparison.A review of labeling concluded that the issue is sufficiently addressed.Based on the results of this investigation, alinity s hiv ag/ab combo reagent kit, ln 6p01-60, lot 37456be00, is performing as expected.No malfunction was identified.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 representative data for cadaveric testing.

• 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: 15780756
• Report Number: 3002809144-2022-00393
• Device Sequence Number: 6741110
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 01/04/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/08/2022; 01/11/2023
• 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) .; ALNTY S SYSTEM, 06P16-01, (B)(6).
• Patient Age: 42 YR
• Patient Sex: Female