BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4812947 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61659
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    January 29, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED SHE WAS HOSPITALIZED AFTER SLIPPING INTO A HYPOGLYCEMIC COMA WHERE HER BLOOD GLUCOSE WAS 0 MG/DL. CUSTOMER BELIEVED THAT THE EXPERIMENTAL DRUG SHE WAS TAKING AT THE TIME WAS A CONTRIBUTING FACTOR. EMERGENCY MEDICAL TECHNICIANS WERE CALLED AND WERE UNABLE TO BRING HER BLOOD GLUCOSE READINGS UP, SO SHE WAS TAKEN TO THE HOSPITAL. AFTER THE CUSTOMER'S BLOOD GLUCOSE ROSE, SHE WOKE UP AND WAS RELEASED FROM THE HOSPITAL A DAY LATER. THE CUSTOMER WAS NOT SURE IF SHE WAS WEARING THE INSULIN PUMP AT THE TIME EMERGENCY MEDICAL SERVICES WERE CALLED, BUT STATED SHE BELIEVED IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354834 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization