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	12/20/2023
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.Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false reactive alinity s hiv ag/ab combo results for a 16-year-old female donor.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) initial result, on (b)(6) 2023, was 1.99, repeat results were 1.32 and 1.34 s/co.The sample was confirmed positive on the geenius platform on (b)(6) 2023.The sample was negative with hivnt.The sample was sent out for testing on the grifols platform and the hivnt was negative and the geenius testing was weak and resulted as hiv-1 positive (hiv-1ab reactive/hiv-2 indeterminate).The western blot results showed gp36, gp160, and p24 absent but gp140, p31, gp41, and ctrl were present.The donor was redrawn on (b)(6) 2024, under sample id (b)(6), initial result, tested on (b)(6) 2024, was 1.04, repeat results were 0.97 and 0.96 s/co.The nat was negative.There was no impact to patient or donor management reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s hiv ag/ab combo results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Trending review determined no related trend for the issue and the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot number, 53198be00, and complaint issue.The overall reactive rates of list number 06p01-60, lot number 53198be00, at versiti indiana (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 initial reactive rate (irr), repeat reactive rate (rrr), and specificity (assuming zero prevalence) observed for lot 53198be00 at the customer site and their peer sites is within product requirements and comparable to other lots analyzed in the comparison.At the customer of interest, the complaint lot performs better than at peer sites and comparably to earlier and later lots used at the site.The whole blood and plasma monitoring group: irr: 0.020 %, rrr: 0.013 %, irr - rrr 0.007 %, specificity: 99.987 %, versiti indiana (usa): irr: 0.051 %, rrr: 0.029 %, irr - rrr 0.022 %, specificity: 99.971 %, and peer sites: irr: 0.069 %, rrr: 0.042 %, irr - rrr 0.026 %, specificity: 99.958 %.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity s hbsag, lot number 53198be00, is performing as intended and no systemic issue or deficiency was identified.Section b5 - additional information provided by the customer for sample id (b)(6) drawn on (b)(6) 2024 was updated to sample id (b)(6).
Event or Problem Description
The customer observed false reactive alinity s hiv ag/ab combo results for a 16-year-old female donor.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) initial result, on (b)(6) 2023, was 1.99, repeat results were 1.32 and 1.34 s/co.The sample was confirmed positive on the geenuis platform on (b)(6) 2023.The sample was negative with hivnt.The sample was sent out for testing on the grifols platform and the hivnt was negative and the geenius testing was weak and resulted as hiv-1 positive (hiv-1ab reactive/hiv-2 indeterminate).The western blot results showed gp36, gp160, and p24 absent but gp140, p31, gp41, and ctrl were present.The donor was redrawn on (b)(6) 2024, under sample id (b)(6), initial result, tested on (b)(6) 2024, was 1.04, repeat results were 0.97 and 0.96 s/co.The nat was negative.There was no impact to patient or donor 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18686675
• Report Number: 3002809144-2024-00035
• Device Sequence Number: 7242749
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/07/2024

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: 05/31/2024
• Device Catalogue Number: 06P01-60
• Device Lot Number: 53198BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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, AS1295; ALNTY S SYSTEM, 06P16-01, AS1295
• Patient Age: 16 YR
• Patient Sex: Female