BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232436 · Received August 25, 2011

    Report

    Report Number
    2032227-2011-02172
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 DUE TO HIGH BLOOD GLUCOSE LEVELS AND A URINARY TRACT INFECTION. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 356 MG/DL AT THE TIME OF ADMISSION. AT THE TIME OF THE CALL, THE SCREEN WAS BLANK. ADVISED THE CALLER TO REMOVE THE BATTERY FOR TEN MINUTES, INSERT A NEW BATTERY AND CALL BACK IF THE SCREEN DOES NOT RETURN TO NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization