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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Alinity s anti-hcv testing was performed for a us clinical trial donor re-entry sample, id (b)(6), on (b)(6) 2021.The result was nonreactive at (b)(6) s/co.Testing using the alinity s anti-hcv ii assay was repeat reactive ((b)(6) and (b)(6) s/co).Nat was negative.Ortho anti-hcv testing was repeat reactive.This donor was deferred during initial clinical trial testing for the alinity s anti-hcv ii assay on (b)(6) 2021.The results were as follows: alinity s anti-hcv: (b)(6) s/co nonreactive.Alinity s anti-hcv ii: (b)(6) and (b)(6) s/co repeat reactive.Nat: negative.Roche anti-hcv: reactive.During the initial clinical trial testing on (b)(6) 2021, the correct result for the donor sample was determined to be reactive.The alinity s anti-hcv result generated on (b)(6) 2021 is considered to be a potential false nonreactive.It is unknown which result the customer believes is correct for this donor.No impact to patient or donor management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient/donor details are not available.
Additional Manufacturer Narrative
Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.To evaluate clinical sensitivity, (b)(4) replicates of two sensitivity panels (anti-hcv panel a (core only) and anti-hcv panel b (ns3 only)) were tested.The sensitivity panels met specifications.No false non-reactive results were obtained.Additionally, two commercially available seroconversion panels (zeptometrix hcv seroconversion panels hcv9045 and hcv9047) were tested.Alinity s anti-hcv reagent lot 28455be00 detected the same first bleed as reactive compared to historical results for alinity s anti-hcv.Further, additional replicates of the positive control were tested which all met specifications.Based on the investigation, alinity s anti-hcv reagent lot 28455be00 is performing as expected.

• 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 ; 433331157
• MDR Report Key: 13473688
• Report Number: 3002809144-2022-00044
• Device Sequence Number: 3963406
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 200
• 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): 03/17/2022

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: 04/26/2022
• Device Catalogue Number: 06P04-60
• Device Lot Number: 28455BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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