BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON DRUG CALIBRATOR 2

    MDR report key: 2504651 · Received March 26, 2012

    Report

    Report Number
    2050012-2012-00823
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DLJ
    PMA / PMN Number
    K993473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER REPORTED THAT THEY RECEIVED A VIAL OF DRUG CALIBRATOR 2 THAT HAD LEAKED APPROXIMATELY 2 MLS IN THE BOX DURING TRANSIT. CUSTOMER STATED THAT THE LEAK WAS CAUSED BY A LOOSE CAP. NO INJURY OR EXPOSURE WAS REPORTED DUE TO THE LEAK. IT WAS DECIDED THAT AN MDR SHOULD BE FILED FOR THIS EVENT BECAUSE THE PRODUCT CONTAINS MATERIAL OF HUMAN ORIGIN, WHICH MAY BE POTENTIALLY INFECTIOUS, AND UPON RECUR COULD CAUSE SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1