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 false nonreactive alinity s anti-hcv results on one donor specimen when compare to anti-hcv ii results during design validation and clinical study processes.That donor initially deferred during hcv ii clinical trials.Those results used for patient management and provided were: initial sid: (b)(6).Initial hcv result: nr.Initial hcv ii result: rr.Initial nat result: neg.Initial roche result: r.The donor came back for re-entry and tested on (b)(6) 2022.Re-entry sid: (b)(6).Re-entry hcv result: nr (no actual results provided).Re-entry hcv ii result= (b)(6), (b)(6), (b)(6), s/co (> or = 1.00 s/co=reactive).Re-entry nat result: nr.Re-entry ortho result: nr.The alinity s anti-hcv result generated on (b)(6) 2022 is considered to be a potential false nonreactive.It is unknown which result the customer believes is correct for this donor.There was no reported imapct to patient management.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6) and (b)(6).There was no further information provided by the customer for donors.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Complete information for section a patient information, (b)(6).There was no further information provided by the customer for donors.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed (b)(6) alinity s anti-hcv results on one donor specimen when compare to (b)(6) results during design validation and clinical study processes.(b)(6).It is unknown which result the customer believes is correct for this donor.There was no reported imapct to patient management.
Additional Manufacturer Narrative
This submission is being submitted to update section h6: adverse event problem: updated type of investigation: to b02 from b01.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data history of alinity s anti-hcv reagent, ln 6p04-60, lot number 27308be00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.In-house sensitivity testing was performed with 112 replicates of two sensitivity panels (anti-hcv panel a (core only) and anti-hcv panel b (ns3 only) and all specifications met specification.The clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hcv 9047 and hiv 9045).The seroconversion panel results were compared to historical alinity s anti-hcv test results provided by zeptometrix.The lots 27308be00 and 28455be00 detected the same bleeds as reactive for the seroconversion panels, additional replicates of the positive control were tested which all met specifications.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity s anti-hcv reagent, lot number, 27308be00.

• 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: 13457703
• Report Number: 3002809144-2022-00042
• Device Sequence Number: 4853892
• 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: 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,Followup
• Report Date (Section B): 03/18/2022

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: 03/16/2022; 03/16/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/17/2022; 03/19/2022
• 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
• Usage of Device: Unknown
• 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)
• Patient Sex: Unknown