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	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nbii hold 4/17 the customer reported an increase in initial reactive and repeat reactive results when using the alinity s hiv ag/ab combo assay for the month of(b)(6) 2023.The following sids and reagent lot number affected that generated repeat reactive results on the alinity s system but tested negative on the customer¿s confirmatory bio-rad geenius hiv 1 / 2 assay (actual values were not provided): lot 46383be00: w045023022651, w036923300542, w121023001931, w280323110314, w045023028801, w045023022745, w089223000404, w141823000526, w051523506592,w087923302890.There was no impact to patient management reported.
Additional Manufacturer Narrative
Patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Evaluation of complaint data for alinity s hiv ag/ab combo reagent lot 46383be00 did not identify an increase in complaint activity for the complaint issue.Trending data was reviewed, and no related trends were identified.Return testing was not completed as returns were not available.A review of labeling concluded that the issue is sufficiently addressed.The performance of lot 46383be00 was investigated by completing a device history record review and did not identify any non-conformances, potential non-conformances and deviations related to the reagent lot and complaint issue.A technical review of field data for alinity s hiv ag/ab combo was performed.Overall reactive rates of lot 46383be00 at innovative blood resources inc (ibr), usa., 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 customer and their peer sites, the performance for lot 46383be00 is within product requirements and comparable to other lots analyzed in the comparison.Based on the investigation, alinity s hiv ag/ab combo reagent lot 46383be00 is performing as intended, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported an increase in initial reactive and repeat reactive results when using the alinity s hiv ag/ab combo assay for the month of march 2023.The following sids and reagent lot number affected that generated repeat reactive results on the alinity s system but tested negative on the customer¿s confirmatory bio-rad geenius hiv 1 / 2 assay (actual values were not provided): lot 46383be00: w045023022651, w036923300542, w121023001931, w280323110314, w045023028801, w045023022745, w089223000404, w141823000526, w051523506592,w087923302890 there was no impact to patient management reported.

• 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: 16747126
• Report Number: 3002809144-2023-00193
• Device Sequence Number: 3366245
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 11/12/2023
• Device Catalogue Number: 06P01-60
• Device Lot Number: 46383BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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)
• Patient Sex: Unknown