MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT; HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)

Catalog Number	06P04-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
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.Patient identifier complete entry = for patient identifiers.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false reactive alinity s anti-hcv results for two donors.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): donor 1 bleed number 5530394908 initial result, on (b)(6) 2022, was 2.21, repeat was 1.83 s/co, nat with grifols assay was negative; bleed number 5530395212 initial result, on (b)(6) 2022, was 1.3, repeats were 1.42 and 1.45 s/co, nat with grifols assay was negative, supplemental testing with ortho assay was positive; bleed number 5530395471 initial result, on (b)(6) 2022, was 0.99 s/co, nat with grifols assay was negative; bleed number 5530394908 initial result, on (b)(6) 2022, was 2.27, repeats were 1.96 and 1.73 s/co, no additional testing was performed for this specimen.Donor 2 bleed number 5530394626 initial result, on (b)(6) 2022, was 1.11, repeats were 0.99 and 1.01 s/co, nat with grifols assay was negative, supplemental testing with ortho assay was positive; bleed number 5530394872 initial result, on 19aug2022, was 0.77, repeat was 0.73 s/co, nat with grifols assay was negative; bleed number 5530395180 initial result, on (b)(6) 2022, was 0.71 s/co, nat with grifols assay was negative.There was no impact to donor or patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s anti-hcv 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, 40181be00, and complaint issue.The overall reactive rates of list number 06p04-60, lot 40181be00, across biomat usa inc, applicable peer sites, and across all us customer sites were collected and assessed.Across all us blood screening customers, the initial reactive rate (irr), repeat reactive rate (rrr), and specificity (assuming zero prevalence) observed for lot 40181be00 is within product requirements, within package insert representative data, and comparable to other lots analyzed in the comparison: lot 40181be00: irr: 0.095%, rrr: 0.095%, irr - rrr: 0.001%, specificity: 99.905%.At biomat usa inc, the performance of lot 40181be00 is within product requirements and within package insert representative data: lot 40181be00: irr: 0.112%, rrr: 0.111%, irr - rrr: 0.001%, specificity: 99.889%.Peer sites: lot 40181be00: irr: 0.093%, rrr: 0.092%, irr - rrr: 0.001%, specificity: 99.908%.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity s anti-hcv, lot number 40181be00, is performing as intended and no systemic issue or deficiency was identified.

• Brand Name: ALINITY S ANTI-HCV REAGENT KIT
• Common Device Name: HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)
• 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: 16004833
• Report Number: 3002809144-2022-00446
• Device Sequence Number: 6678746
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125677
• 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): 02/17/2023

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: 03/08/2023
• Device Catalogue Number: 06P04-60
• Device Lot Number: 40181BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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