BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON SYSTEMS DRUG CALIBRATOR 2

    MDR report key: 2551130 · Received April 26, 2012

    Report

    Report Number
    2050012-2012-01057
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 13, 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

    CUSTOMER DID NOT FIND ANY VISIBLE DAMAGE TO THE VIALS, AND DID NOT RETURN THE SHIPMENT FOR INSPECTION. ALTHOUGH THE CAUSE OF THE VIAL LEAK WAS NOT DETERMINED, IT MAY BE ASSUMED THAT THE CONTAINER WAS CRACKED OR DAMAGED DUE TO TRANSIT OF THE SHIPMENT. A BECKMAN COULTER, INC REPRESENTATIVE SENT TWO REPLACEMENT KITS TO CUSTOMER. (B)(4). CUSTOMER DID NOT RETURN SHIPMENT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT A NEW KIT OF SYNCHRON SYSTEMS DRUG CALIBRATOR 2 WAS OPENED, AND VIAL / LEVEL #5 WAS FOUND NEARLY EMPTY. CUSTOMER NOTICED EVIDENCE OF LEAKAGE INSIDE THE BOX. CUSTOMER THEN OPENED A SECOND KIT OF THE SAME LOT, LOT #M101710, AND FOUND THAT VIAL / LEVEL #6 WAS COMPLETELY EMPTY. AGAIN, CUSTOMER NOTICED EVIDENCE OF LEAKAGE INSIDE THE BOX. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, EYE PROTECTION / GOGGLES AND GLOVES. 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. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1