BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232609 · Received August 25, 2011

    Report

    Report Number
    2032227-2011-02167
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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

    THE CUSTOMER CALLED FOR ASSISTANCE IN TURNING OFF THE BG REMINDER. THE CUSTOMER THEN STATED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WAS ILL WITH A VIRUS YESTERDAY, AND DOESN'T FEEL THAT THE HOSPITALIZATION WAS INSULIN PUMP RELATED. 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-522PNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization