BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HAV IGM ASSAY

    MDR report key: 2445688 · Received February 10, 2012

    Report

    Report Number
    1219913-2012-00053
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    October 18, 2011
    Report Date
    January 10, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOL
    PMA / PMN Number
    K081716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HAV IGM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.EXPIRATION DATE FOR LOT # 154 IS 07/11/2013.

    Description of Event or Problem · 1

    A POSITIVE ADVIA CENTAUR HAV IGM RESULT WAS OBTAINED FOR SAMPLES FROM ONE PATIENT. THE PATIENT SAMPLE WAS TESTED BY AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS ALSO TESTED AT A REFERENCE LABORATORY WITH PCR TESTING AND THE RESULT WAS NEGATIVE. TREATMENT WITH CYCLOSPORINE WAS DELAYED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HAV IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HAV IGM ASSAY HEPATITIS A VIRUS IGM ASSAY LOL SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 153 AND 154

    Patients

    Seq Age Sex Outcome Treatment
    1