BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON DRUG CALIBRATOR 1

    MDR report key: 2551117 · Received April 26, 2012

    Report

    Report Number
    2050012-2012-01058
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DKB
    PMA / PMN Number
    K955644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REAGENT SHIPMENT NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SMALL DROPLETS OF DRIED SYNCHRON DRUG CALIBRATOR 1, LOT #M103090, WERE OBSERVED ON THE INSIDE OF THE BOX AND AROUND THE CAPS OF SOME OF THE BOTTLES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. CUSTOMER WAS SENT A REPLACEMENT. THE LEAKAGE WAS DUE TOO LOOSE CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON DRUG CALIBRATOR 1 CALIBRATORS, DRUG MIXTURE DKB BECKMAN COULTER, INC. NA M103090

    Patients

    Seq Age Sex Outcome Treatment
    1