BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 22320495 · Received June 24, 2025

    Report

    Report Number
    3002809144-2025-00200
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 24, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740162665
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NON-REACTIVE ALINITY I ANTI-HCV RESULTS 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 BATCH HISTORY REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HCV ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 67328BE01. THE DEVICE HISTORY RECORD REVIEW DOES NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER(S) AND COMPLAINT ISSUE. A REVIEW OF RELEASE DATA HAS BEEN PERFORMED FOR ALINITY I ANTI-HCV REAGENT LOT NUMBER 67328BE01. THE NEGATIVE CONTROL, POSITIVE CONTROLS, AND TWO POSITIVE PANELS WERE ALL WELL WITHIN THEIR SPECIFICATION LIMITS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I ANTI-HCV REAGENT KIT FOR LOT NUMBER 67328BE01 WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P06 (ALINITY I ANTI-HCV) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05 (ANTI-HCV) WITH 510K/PMA/BLA NUMBER P050042. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN H6 - ADVERSE EVENT PROBLEM, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY NON-REACTIVE ALINITY I ANTI-HCV FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE <1) ANTI-HCV RESULT = 0.67 S/CO, ROCHE RESULT = POSITIVE (NO SPECIFIC DATA PROVIDED) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY NON-REACTIVE ALINITY I ANTI-HCV FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 1). ANTI-HCV RESULT = 0.67 S/CO, ROCHE RESULT = POSITIVE (NO SPECIFIC DATA PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064880 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 67328BE01 00380740162665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, AI27060| ALNTY I PROCESSING MODU, 03R65-01, AI27060