BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAP

    MDR report key: 1964024 · Received January 10, 2011

    Report

    Report Number
    2032227-2011-00071
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD BEEN DRIVING UNDER THE INFLUENCE OF ALCOHOL, AND WAS PULLED OVER BY THE POLICE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED WITH THE WRONG LANGUAGE AND TIME. AFTER CORRECTING, VERIFIED ALL OTHER PROGRAMMING WAS CORRECT. ALSO, FOUND THAT THE CUSTOMER HAD BEEN GETTING NO DELIVERY ALARMS, BUT DIDN'T CHANGE THE INFUSION SET. THE WIFE HAD NO SUPPLIES AT THE TIME OF THE CALL TO CONDUCT THE PRIME OR HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAP PARADIGM REAL-TIME INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization