BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 902834 · Received August 23, 2007

    Report

    Report Number
    MW5003523
    Event Type
    Other
    Date Received
    August 23, 2007
    Report Date
    August 23, 2007
    Manufacturer
    SAN VITA
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SON WHO IS A TYPE 1 DIABETES PT HAD BG OF 380 AT 3AM. CORRECTIONAL INSULIN BOLUS WAS GIVEN, BUT BS WAS NOT COMING DOWN. CONTROL SOLUTION CHECKED INDICATED PT RECEIVED ALL INSULIN GIVEN WHICH CREATED MEDICAL EMERGENCY. INSULIN WAS NOT GETTING TO THE BRAIN WHICH COULD CAUSE SEIZURES. ALL 3 METERS WE OWN ARE INACCURATE. I BELIEVE IN MY PERSONAL EXPERIENCE THAT THIS NEEDS TO BE INVESTIGATED BY FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED GLUCOMETER PARADIGM BD NBW SAN VITA HMS- 322201

    Patients

    Seq Age Sex Outcome Treatment
    1 YR