BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON SYSTEMS DRUG CALIBRATOR 2

    MDR report key: 2478719 · Received March 5, 2012

    Report

    Report Number
    2050012-2012-00650
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DLJ
    PMA / PMN Number
    K993473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER, OTHER: CUSTOMER DISCARDED THE REAGENT. (B)(4). OTHER TEXT: PRODUCT DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(4) 2012, CUSTOMER REPORTED THAT THEY RECEIVED A VIAL OF DRUG CALIBRATOR 5 THAT HAD LEAKED IN THE BOX. NO INJURY WAS REPORTED DUE TO THE EXPOSURE. REPLACEMENT WAS SENT OVERNIGHT. IT WAS DETERMINED THAT AN MDR SHOULD BE FILED BECAUSE THE PRODUCT CONTAINS MATERIAL OF HUMAN ORIGIN AND UPON RECUR, UNPROTECTED CONTACT WITH THE PRODUCT IS POTENTIALLY INFECTIOUS, AND COULD CAUSE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON SYSTEMS DRUG CALIBRATOR 2 CALIBRATORS, DRUG SPECIFIC DLJ BECKMAN COULTER, INC. M101710

    Patients

    Seq Age Sex Outcome Treatment
    1