BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON DRUG CALIBRATOR 2

    MDR report key: 2308912 · Received October 26, 2011

    Report

    Report Number
    2050012-2011-06414
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 27, 2011
    Report Date
    September 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DLJ
    PMA / PMN Number
    K993473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IS FILING THIS MDR BECAUSE DRUG CALIBRATOR 3 REAGENT CONTAINS MATERIALS OF HUMAN OR ANIMAL ORIGIN AND SHOULD BE CONSIDERED AS POTENTIALLY CAPABLE OF TRANSMITTING INFECTIOUS DISEASES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED AN EMPTY VIAL OF DRUG CALIBRATOR 3. ACCORDING TO CUSTOMER, THE REAGENT APPEARED TO HAVE LEAKED OUT FROM THE VIAL. CUSTOMER REPORTED THAT THERE WAS NO CRACK ON THE VIAL. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON DRUG CALIBRATOR 2 CALIBRATORS, DRUG SPECIFIC DLJ BECKMAN COULTER, INC. DRUG CALIBRATOR 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1