MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number	08P05-21
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete sid: (b)(6).Section 4 lot# and primary udi updated.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false nonreactive alinity i anti-hcv result on a patient.The following results were provided: (b)(6) 2024 sid (b)(6) = 0.40 s/co, repeated (b)(6) 2024 on architect = 5.59 / 5.46 s/co.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation was performed for a false non-reactive result with the alinity i anti-hcv assay (lot# 58172be00) which included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.A retained kit of reagent lot 58172be00 was tested for sensitivity and the data shows that the performance of lot 58172be00 is not negatively impacted.Labeling review concluded that the issue is adequately addressed.Based on our investigation, no systemic issue or product deficiency of the alinity i anti-hcv reagent lot 58172be00 was identified.
Event or Problem Description
The customer reported a false nonreactive alinity i anti-hcv result on a patient.The following results were provided: (b)(6) 2024 sid (b)(6) = 0.40 s/co, repeated(b)(6) 2024 on architect = 5.59 / 5.46 s/co.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false nonreactive alinity i anti-hcv result on a patient.The following results were provided: (b)(6) 2024 sid (b)(6) = 0.40 s/co, repeated (b)(6) 2024 on architect = 5.59 / 5.46 s/co.No impact to patient management was reported.

• Brand Name: ALINITY I ANTI-HCV REAGENT KIT
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• 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: 19311120
• Report Number: 3002809144-2024-00140
• Device Sequence Number: 3063305
• Product Code: MZO
• UDI-Device Identifier: 00380740130657
• UDI-Public: (01)00380740130657(17)240923(10)58172BE00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 06/21/2024

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: 09/23/2024
• Device Catalogue Number: 08P05-21
• Device Lot Number: 58172BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/21/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/03/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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 I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01,(B)(6)
• Patient Sex: Unknown