BEUDAMED
    FDA Adverse Event Summary report: N

    GLUCOSE MONITORING SYS/KIT

    MDR report key: 2990817 · Received March 5, 2013

    Report

    Report Number
    3008382007-2013-04271
    Date Received
    March 5, 2013
    Report Date
    February 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 97 MG/DL ON THE REPORTED METER AND 43 MG/DL ON ANOTHER METER. THE TESTS WERE REPORTEDLY TAKEN WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT TESTED BECAUSE THEY WERE "FEELING SYMPTOMS OF N HYPO" PRIOR TO TESTING, AND STATED THAT NO FURTHER SYMPTOMS DEVELOPED. THE PATIENT DENIED SEEKING ANY MEDICAL ATTENTION OR TREATMENT AS A RESULT OF THE ISSUE. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92950 GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR