BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON DIGOXIN (DIGN)

    MDR report key: 234364 · Received July 26, 1999

    Report

    Report Number
    2050010-1999-00002
    Event Type
    Malfunction
    Date Received
    July 26, 1999
    Date of Event
    June 26, 1999
    Report Date
    July 21, 1999
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY WERE USING BECKMAN COULTER DIGOXIN REAGENT ('DIGN') LOT NUMBER M906076 ON A SYNCHRON CX7 INSTRUMENT AND OBTAINED AN OIR LO RESULT. THE SAMPLE WAS RE-RUN USING 'DIG' REAGENT AND AN OIR HI RESULT WAS OBTAINED. CUSTOMER REPORTED THE RESULT AS <0.2 SAMPLE WAS RE-RAN USING BOTH 'DIG' AND 'DIGN' WITH RESULTS FOR 'DIG' IN THE THERAPEUTIC RANGE AND 'DIGN' RESULTS FROM 0.2-0.5NG/ML. CUSTOMER BELIEVES THE LOWER RESULTS USING 'DIGN' REAGENT ARE INCORRECT. INCORRECT LOW DIGOXIN RESULTS, USED FOR DOSAGE DECISIONS COULD CAUSE ADDITIONAL DIGOXIN TO BE ADMINISTERED THAT COULD PLACE THE LEVELS IN THE TOXIC RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON DIGOXIN (DIGN) CLINICAL CHEMISTRY REAGENT KXT BECKMAN COULTER, INC. SYNCHRON CX M906076

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other