BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2090106 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01177
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 17 MG/DL. TROUBLESHOOTING WAS PERFORMED. FOUND THAT PRIOR TO THE EVENT, THE CUSTOMER ACCIDENTALLY PROGRAMMED A BOLUS OF 20.0 UNITS INSTEAD OF PROGRAMMING 0.2 UNITS. ALL OTHER PROGRAMMING WAS CORRECT. ADVISED THE CUSTOMER THAT THE MAXIMUM BOLUS AMOUNT CAN BE LOWERED TO PREVENT THIS FROM HAPPENING AGAIN, BUT SHE DECLINED. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization