BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON SYSTEM DRUG CALIBRATOR 2

    MDR report key: 2482758 · Received March 7, 2012

    Report

    Report Number
    2050010-2012-00012
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DLJ
    PMA / PMN Number
    K993473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES - RESULTS CODE - (OTHER): VIAL. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY FOUND THE LEVEL 5 VIAL HAD LEAKED WHEN THEY OPENED A NEW BOX OF SYNCHRON SYSTEM DRUG CALIBRATOR 2 TO PERFORM A CALIBRATION. CUSTOMER REPORTED THAT THE VIAL APPEARED TO BE DAMAGED. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS APPROXIMATELY 2 ML. 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 SYSTEM DRUG CALIBRATOR 2 CALIBRATORS, DRUG SPECIFIC DLJ BECKMAN COULTER, INC. DRUG CALIBRATOR 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1