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	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false reactive alinity s anti-hcv on (b)(6) 2023 and provided the following data: sample id (b)(6) was initial reactive and repeat reactive (no objective values provided.) confirmatory testing with nat was performed and the customer reported that the confirmatory results were negative.Customer stated that they have sent sample out to a reference lab.There was no reported impact to patient management.
Event or Problem Description
The customer reported false reactive alinity s anti-hcv on (b)(6) 2023 and provided the following data: sample id (b)(6) was initial reactive and repeat reactive (no objective values provided.) confirmatory testing with nat was performed and the customer reported that the confirmatory results were negative.Customer stated that they have sent sample out to a reference lab.There was no reported impact to patient management.Update: additional information received: the customer reported that sample 04816440665 was resulted as hcv pcr negative on (b)(6) 2023.The sample was sent out for additional testing, which generated positive hcv result (eia method) on (b)(6) 2023.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any potential non-conformances, non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.The ticket trending review did not identify any trends.The overall performance of the alinity s anti-hcv reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 54315be00 indicated the product was performing within product requirements.Labeling was reviewed and was found to address the customer reported issue.Based on the results of the investigation, alinity s anti-hcv reagent lot 54315be00 met performance specifications and no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported false reactive alinity s anti-hcv on(b)(6)2023 and provided the following data: sample id (b)(6)was initial reactive and repeat reactive (no objective values provided.) confirmatory testing with nat was performed and the customer reported that the confirmatory results were negative.Customer stated that they have sent sample out to a reference lab.There was no reported impact to patient management.Update: additional information received: the customer reported that sample (b)(6)was resulted as hcv pcr negative on (b)(6)2023.The sample was sent out for additional testing, which generated positive hcv result (eia method) on (b)(6)2023.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18422906
• Report Number: 3002809144-2023-00507
• Device Sequence Number: 7867257
• 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,Followup
• Report Date (Section B): 02/08/2024

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: 06/27/2024
• Device Catalogue Number: 06P04-60
• Device Lot Number: 54315BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/02/2024; 02/02/2024
• Initial Report FDA Received Date: 12/30/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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); ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown