BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON DRUG CALIBRATOR 2

    MDR report key: 2461085 · Received February 17, 2012

    Report

    Report Number
    2050012-2012-00420
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 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

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT CALIBRATOR #3 WAS EMPTY WHEN THEY OPENED THE BOX AND UNCAPPED THE SYNCHRON SYSTEM DRUG CALIBRATOR 2 CARTRIDGE. CUSTOMER REPORTED THAT THERE WAS A LOOSE CAP AND CALIBRATOR #3 LEAKED ALL THROUGH THE BOX. 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