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	09/11/2022
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.(b)(4): mfr 3002809144-2022-00361-00 is for sid (b)(6).(b)(4): mfr 3002809144-2022-00362-00 is for sid (b)(6).(b)(4): mfr 3002809144-2022-00363-00 is for sid (b)(6).(b)(4): mfr 3002809144-2022-00364-00 is for sid (b)(6).(b)(4): mfr 3002809144-2022-00365-00 is for sid (b)(6).(b)(4): mfr 3002809144-2022-00366-00 is for sid (b)(6).(b)(4): mfr 3002809144-2022-00367-00 is for sid (b)(6).
Event or Problem Description
The customer observed false repeat reactive alinity s hiv ag/ab results for multiple cadaveric samples.The following data was provided (units of measure = s/co): (b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 2.96, repeats = 5.37 and 3.34.(b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 2.03, repeats = 6.01 and 2.90.(b)(6) 2022: sid: (b)(6).(serial (b)(4), lot 34376be00) initial result = 3.52, repeats = 9.78 and 7.32.(b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 27.79, repeats = 6.12 and 3.89.(b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 6.67, repeats = 5.51 and 3.77 (b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 1.07, repeats = 1.18 and 1.55.(b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 1.74, repeats = 3.39 and 2.26.(b)(6) 2022: sid: (b)(6).(serial (b)(4) , lot 34376be00) initial result = 3.52, repeats = 3.41 and 4.84.Additional information was provided by the customer on 13oct2022: the associated tissues were all discarded as it is laboratory policy to discard any tissue with repeat reactive results.The testing issues are related to tissue and eye (cadaveric) samples.The associated tissues were 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, labeling review, device history record review, and field data review.Return testing was not performed 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 and deviations with lot 34376be00 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.A technical review of field data for alinity s hiv ag/ab was performed.Overall reactive rates of lot 34376be00 across bwnw (the customer¿s site), 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 34376be00 is within product requirements, within package insert representative data for cadaveric specimens and comparable to other lots analyzed in the comparison.At bwnw the performance of lot 34376be00 is within package insert representative data for cadaveric specimens and comparable to peer sites.Per the complaint documentation, the customer identified these results were associated with a specific work shift.They identified this shift was not visually examining samples or re-processing them as part of their pre-analytics.Re-education of this shift on the customer¿s pre-analytics processes resolved the issue of increased reactives with cadaveric samples.Based on the investigation alinity s hiv ag/ab reagent lot 34376be00 is performing as intended, no systemic issue or deficiency of the 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: 15666777
• Report Number: 3002809144-2022-00368
• Device Sequence Number: 19523482
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/18/2022

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: 05/28/2023
• Device Catalogue Number: 06P01-60
• Device Lot Number: 34376BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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); ALNTY S SYSTEM, 06P16-01, (B)(6)
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown