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	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed potential (b)(6) alinity s anti-hcv results on one donor specimen when compare to (b)(6) results.That donor initially deferred during (b)(6) clinical trials and tested again for re-entry.Those results used for patient management and provided were: initial sid: (b)(6); initial (b)(6) result: (b)(6); initial (b)(6) result: (b)(6); initial (b)(6) result: (b)(6); initial (b)(6) result: (b)(6).On (b)(6) 2022: re-entry sid: (b)(6); re-entry (b)(6) result: (b)(6); re-entry (b)(6) result: (b)(6) (initial: (b)(6), repeat: (b)(6)); re-entry (b)(6) result: (b)(6); re-entry (b)(6) result: (b)(6).It is unclear which results are correct.There was no impact to patient management reported.
Additional Manufacturer Narrative
(b)(6).All available patient information is included.Additional patient details are not available.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for false nonreactive alinity s anti-hcv results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The complaint activity was reviewed and identified normal complaint activity for the lot number.Tracking and trending were reviewed, and no related trends were identified.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 27308be00 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.The device history records were reviewed and did not identify any non-conformances, potential non-conformances, or deviations.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity s anti-hcv reagent lot 27308be00 was identified.D4 - expiration date: initial: (b)(6) 2022.Corrected: 2022-03-29 h4 - device mfg date: initial: 2021-02-15 / corrected: 2021-04-27.

• 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: 13429609
• Report Number: 3002809144-2022-00039
• Device Sequence Number: 12100928
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 03/29/2022
• Device Catalogue Number: 06P04-60
• Device Lot Number: 27308BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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