BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090923 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01090
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. PRIOR TO THE EVENT, THE CUSTOMER WENT TO BED WITH NORMAL BLOOD GLUCOSE LEVELS. TWO HOURS LATER, THE CUSTOMER WOKE UP WITH ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER BOLUSED AND WENT TO BED. THE CUSTOMER WOKE UP EVERY TWO HOURS AFTER THAT, AND ONCE THE BLOOD GLUCOSE LEVELS REACHED 28 MMOL/L, THE CUSTOMER DECIDED TO GO TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED, THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. DURING THE PRIME TEST, THE INSULIN PUMP ALARMED LOW RESERVOIR. 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-522LCAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization