BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2886801 · Received December 27, 2012

    Report

    Report Number
    3008382007-2012-09006
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN THE USA ALLEGING THE METER WAS READING INACCURATELY COMPARED TO THE SAME METER. THE REPORTER ALLEGED OBTAINING READINGS OF "150, 375, 317MG/DL" ON THE SAME METER WITHIN 20 MINUTES OF ONE ANOTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% OR <=20MG/DL. THE REPORTER STATED 30 MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, HE HAD SYMPTOMS OF "URINATION." THE REPORTER STATED HE USES INSULIN 4 OR MORE TIMES A DAY. IT IS UNKNOWN IF HE MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. HOWEVER THE REPORTER DENIED RECEIVING ANY TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE REPORTER STATED DEVELOPING SYMPTOMS PRIOR TO THE START OF THE ALLEGED ISSUE, THEREFORE, THE METER COULD NOT HAVE CAUSED THE ALLEGED SYMPTOMS. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER MADE A METER VS. THE SAME METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE RESULTS MEETS LFS' CRITERIA FOR PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3334618

    Patients

    Seq Age Sex Outcome Treatment
    1