BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2101522 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81550
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. MEDWATCH 2 OF 2 (RESERVOIR): 3004209178-2011-81551.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO BEING HOSPITALIZED, THE CUSTOMER HAD VOMITED AND LOST CONSCIOUSNESS. THE CUSTOMER'S MOTHER'S PERCEIVED CAUSE OF THE EVENT WAS THE UNRESPONSIVE ACT, UP, AND DOWN BUTTONS ON THE INSULIN PUMP THAT LED TO THE CUSTOMER HAVING HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S MOTHER ALSO STATED THAT THERE WERE TWO HALF-INCH LONG CRACKS ON THE RESERVOIR COMPARTMENT OF THE INSULIN PUMP. 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 PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization