BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2062687 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81008
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA AND UNCONSCIOUSNESS. THE CUSTOMER STATED THAT SHE HAD PASSED OUT AND WOKE UP TO FIND PARAMEDICS PROVIDING GLUCOSE INTRAVENOUSLY. THE CUSTOMER ALSO STATED THAT AFTER SHE PASSED OUT, SHE FELL ON HER INSULIN PUMP AND CRACKED THE RESERVOIR COMPARTMENT. THERE WERE NO ALARMS IN THE INSULIN PUMP HISTORY. 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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention