BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 DATE

    MDR report key: 280767 · Received May 25, 2000

    Report

    Report Number
    1810909-2000-00019
    Event Type
    Malfunction
    Date Received
    May 25, 2000
    Date of Event
    April 23, 2000
    Report Date
    May 24, 2000
    Manufacturer
    KDK CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM A HEALTHCARE SOURCE ON BEHALF OF A CUSTOMER WHO BROUGHT A METER TO THE STORE WITH SOME CONCERNS ABOUT THE CUSTOMER'S BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER STATES THAT THEY RAN A TEST ON THEIR METER AND RECEIVED A RESULT OF 55MG/DL. THE CUSTOMER THEN DID A FOLLOW-UP TEST AND RECEIVED A RESULT OF 160MG/DL. THERE WAS LITTLE TIME DIFFERENCE BETWEEN READINGS, BUT IT IS UNKNOWN IF THE TESTS WERE FROM THE SAME FINGER PUNCTURE. WHILE ON THE PHONE, ELECTRONIC AND CONTROL TESTS WERE PERFORMED AND WERE FOUND SATISFACTORY. THE INSTRUMENT WAS CODED CORRECTLY FOR THE LOT OF REAGENT. WHILE THE SYSTEM IS OPERATING CORRECTLY, THE CUSTOMER LOST CONFIDENCE WITH THE INSTRUMENT AND REQUESTED A REPLACEMENT. A NEW INSTRUMENT IS BEING PROVIDED AND THE "COMPLAINT SYSTEM" IS BEING RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM A HEALTHCARE SOURCE ON BEHALF OF A CUSTOMER WHO BROUGHT A METER TO THE STORE WITH SOME CONCERNS ABOUT THE CUSTOMER'S BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER STATES THAT THEY RAN A TEST ON THEIR METER AND RECEIVED A RESULT OF 55MG/DL. THE CUSTOMER THEN DID A FOLLOW-UP TEST AND RECEIVED A RESULT OF 160MG/DL. THERE WAS LITTLE TIME DIFFERENCE BETWEEN READINGS, BUT IT IS UNKNOWN IF THE TESTS WERE FROM THE SAME FINGER PUNCTURE. WHILE ON THE PHONE, ELECTRONIC AND CONTROL TESTS WERE PERFORMED AND WERE FOUND SATISFACTORY. THE INSTRUMENT WAS CODED CORRECTLY FOR THE LOT OF REAGENT. WHILE THE SYSTEM IS OPERATING CORRECTLY, THE CUSTOMER LOST CONFIDENCE WITH THE INSTRUMENT AND REQUESTED A REPLACEMENT. A NEW INSTRUMENT IS BEING PROVIDED AND THE "COMPLAINT SYSTEM" IS BEING RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 DATE BLOOD GLUCOSE METER NBW KDK CORP 3901N *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR