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

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

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 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 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.

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 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
• Type of Device: 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
• MDR Text Key: 331668318
• Report Number: 3002809144-2023-00507
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL 125677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 06P04-60
• Device Lot Number: 54315BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2023
• Supplement Dates Manufacturer Received: 01/02/2024; 02/02/2024
• Supplement Dates FDA Received: 01/11/2024; 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)