BEUDAMED
    FDA Adverse Event Other Summary report: N

    REAL TIME BLOOD GLUCOSE MONITOR

    MDR report key: 782432 · Received November 15, 2006

    Report

    Report Number
    MW1041002
    Event Type
    Other
    Date Received
    November 15, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 15, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I WAS SOLD A "REAL TIME" SYSTEM FOR BLOOD GLUCOSE MONITORING FROM MEDTRONIC MINIMED FOR MY 1SON. HE WENT THROUGH 3 HOURS OF TRAINING DURING WHICH WE WERE TOLD THIS WAS NOT APPROVED FOR CHILDREN UNDER 18. THE SYSTEM WAS A DISASTER FOR HIM. IT FELL OUT NUMEROUS TIMES, WOULD NOT STAY ATTACHED DURING ACTIVITY, WAS CUMBERSOME AND COMPLETELY INAPPROPRIATE FOR AN ACTIVE CHILD. WHEN I CONTACTED MINIMED TO RETURN THE SYSTEM, THEY INFORMED ME THAT THEY WOULD BE CHARGING ME ANYWAY. THEY TOLD ME I AGREED TO THAT ALTHOUGH I HAVE ABSOLUTELY NOTHING IN WRITING. IT'S BAD ENOUGH INSURANCE WASN'T COVERING THIS, BUT THE FACT THAT IT SHOULD NOT HAVE EVEN BEEN SOLD TO ME IS OUTRAGEOUS. I AM EXTREMELY UPSET OVER THE HANDLING OF THIS BY MINIMED, SPECIFICALLY THE FACT THAT THEY WOULD SELL ME A SYSTEM THAT WAS NOT APPROVED FOR SOMEONE MY SON'S AGE AND THEN DO NOT STAND BEHIND THEIR PRODUCT WHEN IT IS CLEARLY INAPPROPRIATE. I'M NOT SURE THERE IS ANYTHING YOU CAN OR WILL DO, BUT I WOULD ASK THAT YOU LOOK INTO THIS ON BEHALF OF ALL PARENTS WHO STRUGGLE EACH DAY WITH CHILDREN WITH DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAL TIME BLOOD GLUCOSE MONITOR * NBW MEDTRONIC MINIMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other