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	06/18/2022
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.All available patient/donor information was included.Additional details are not available.
Event or Problem Description
A nonreactive alinity s anti-hcv result of 0.32 s/co was generated for an alinity s anti-hcv ii clinical trial donor re-entry sample (sid (b)(6).The donor was previously deferred during alinity s anti-hcv ii clinical trials.The nonreactive alinity s anti-hcv result of 0.32 s/co is considered to be false nonreactive.Donor re-entry process is conducted for samples that were discrepant during initial clinical trial testing for the alinity s anti-hcv ii assay.Re-entry testing: (b)(6) 2022.Sid (b)(6).Alinity s anti-hcv result: nonreactive 0.32 s/co.Alinity s anti-hcv ii result: repeat reactive 13.59, 13.44, 13.30 s/co.Nat result: nonreactive.Ortho result: nonreactive.Initial testing: (b)(6) 2021.Sid (b)(6).Alinity s anti-hcv result: nonreactive 0.26 s/co.Alinity s anti-hcv ii result: repeat reactive 11.53, 12.06, 12.02 s/co.Nat result: negative.Roche anti-hcv ii result: reactive.No impact to donor or patient management was reported.
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, 112 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, ln 6p04-60, lot 35225be00 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, no deficiency for lot number 35225be00 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: 14987799
• Report Number: 3002809144-2022-00241
• Device Sequence Number: 1674550
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 11/04/2022
• Device Catalogue Number: 06P04-60
• Device Lot Number: 35225BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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