BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2020690 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-80562
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER HAS TREATED HIGH BLOOD GLUCOSE LEVELS WITH A SYRINGE OF 5.0 UNITS. THE PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. NO LEAKS WERE DETECTED AND THE INSULIN PUMP PASSED THE FIXED PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization