BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 23110675 · Received September 22, 2025

    Report

    Report Number
    3002809144-2025-00303
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 14, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION RECEIVED WHICH MAKES A PREVIOUSLY REPORTED ISSUE NON-REPORTABLE. THE CUSTOMER PROVIDED RESULTS FROM OTHER TESTING METHODS. THE SAMPLE WAS TESTED USING WESTERN BLOT METHOD AND HBV RNA AND THE RESULTS WERE BOTH NONREACTIVE. ADDITIONALLY, THE CUSTOMER INDICATED THAT THEY BELIEVE THAT THE ABBOTT RESULT (NONREACTIVE ALINITY I ANTI-HCV) IS CORRECT AND IS NO LONGER QUESTIONING THE RESULT. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P06-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05, WITH 510K/PMA/BLA NUMBER P050042.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT FOR A 55-YEAR-OLD FEMALE PATIENT WITH RENAL MALIGNANCY, POST-RENAL AND POST-LIVER TRANSPLANTS. THE ALINITY I ANTI-HCV RESULT FOR SAMPLE ID (B)(6) WAS 0.5 S/CO (REFERENCE RANGE <1 S/CO). THE SNIBE TEST RESULT WAS 26.26 AU/ML (REFERENCE RANGE 0-5 (REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT FOR A 55-YEAR-OLD FEMALE PATIENT WITH RENAL MALIGNANCY, POST-RENAL AND POST-LIVER TRANSPLANTS. THE ALINITY I ANTI-HCV RESULT FOR SAMPLE ID 133 WAS 0.5 S/CO (REFERENCE RANGE <1 S/CO). THE SNIBE TEST RESULT WAS 26.26 AU/ML (REFERENCE RANGE 0-5 (REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169311 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 73475BE01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)