BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E-ELECSYS ANTI HCV ELECSYS

    MDR report key: 3305621 · Received August 23, 2013

    Report

    Report Number
    1823260-2013-05121
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    July 30, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZO
    PMA / PMN Number
    P090007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. NO INVESTIGATION WAS POSSIBLE AS THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION AND THERE WERE NO SAMPLES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ANTIBODY TO (B)(6) RESULTS FOR ONE PATIENT. THE ANALYZER THE SAMPLES WERE TESTED ON WAS REQUESTED BUT NOT PROVIDED. THE DATE THIS EVENT OCCURRED WAS REQUESTED BUT NOT PROVIDED. THE PATIENT HAD A SAMPLE TESTED AND THE (B)(6) WHICH WAS NON-REACTIVE. THE PATIENT HAD A NEW SAMPLE DRAWN AND THE (B)(6), WHICH WAS NON-REACTIVE. MEANWHILE, THE CUSTOMER TESTED ONE OF THE PATIENT'S SAMPLES ON A FOURTH GENERATION ELISA ANALYZER AND IT WAS (B)(6). THE CUSTOMER TOOK A NEW SAMPLE FROM THE PATIENT AND TESTED IT ON THE ELISA ANALYZER AND IT WAS ALSO (B)(6). INFORMATION ON WHETHER ANY OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE AHCV REAGENT LOT NUMBER WAS 171104 AND THE EXPIRATION DATE WAS 12/30/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409663 COBAS E-ELECSYS ANTI HCV ELECSYS ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS MZO ROCHE DIAGNOSTICS NA 171104

    Patients

    Seq Age Sex Outcome Treatment
    1