BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1415010 · Received July 10, 2009

    Report

    Report Number
    MW5011929
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    May 14, 2009
    Report Date
    July 10, 2009
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'VE HAD QUITE A FEW MORE LOW BLOOD SUGARS, SOME OF WHICH I HAVE NOT BEEN ABLE TO EXPLAIN, SINCE USING MY MMT-396, LOT NUMBER 8200618 INFUSION SETS. ONE OF THESE LOWS ACTUALLY INVOLVED ME GOING TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE, OR NEAR-SYNCOPE - I CAN'T REMEMBER IF I ACTUALLY PASSED OUT-, IN 2009. DOSE OR AMOUNT: NA. DATES OF USE: 3 OR 4 MONTHS. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM QUICK-SETS FPA MEDTRONIC MINIMED 8200618

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization