BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LCAB

    MDR report key: 1974360 · Received January 21, 2011

    Report

    Report Number
    2032227-2011-00161
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 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 UNK 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 TAKEN TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVELS BETWEEN 22 AND 23 MMOL/L. THE CUSTOMER WAS ALSO SPILLING KETONES. THE CUSTOMER'S BASAL RATES WERE ADJUSTED AT THE HOSPITAL, BUT CONTINUED TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS AND KETONES. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization