BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT

    MDR report key: 2306591 · Received October 25, 2011

    Report

    Report Number
    2050012-2011-06298
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Date of Event
    September 26, 2011
    Report Date
    September 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    NQD
    PMA / PMN Number
    K070626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IS FILING THIS MDR BECAUSE CRP REAGENT CONTAINS MATERIALS OF ANIMAL ORIGIN AND SHOULD BE CONSIDERED AS POTENTIALLY CAPABLE OF TRANSMITTING INFECTIOUS DISEASES. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED A DAMAGED C-REACTIVE PROTEIN (CRP) REAGENT PACK. CUSTOMER REPORTED THAT THEY OBSERVED THE LEAK WHILE IN THE PROCESS OF LOADING THE REAGENT ON THE SYSTEM. CUSTOMER REPORTED THAT THEY DID NOT LOAD THE REAGENT ON BOARD. CUSTOMER REPORTED THAT NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED. 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 SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD BECKMAN COULTER, INC. C-REACTIVE PROTEIN KIT M012260

    Patients

    Seq Age Sex Outcome Treatment
    1