BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984076 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91448
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 30MG/DL. IT WAS STATED THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM, AND HE SWITCHED TO THE NEW INSULIN PUMP, WHICH IT WAS PROGRAMMED INCORRECTLY. TROUBLESHOOTING WAS PERFORMED. THE MOTHER REQUESTED ASSISTANCE WITH PROGRAMMING THE DEVICE. THE CALLER MENTIONED THAT THE CUSTOMER RECEIVED 150 UNITS OF INSULIN IN LESS THAN TWELVE HOURS. THE MOTHER STATED THAT THE DEVICE ALARMED BECAUSE THERE WAS NOT ANY INSULIN LEFT IN THE RESERVOIR. WHEN THE PARAMEDICS ARRIVED AT THE CUSTOMER'S HOUSE HIS BLOOD GLUCOSE WAS 30MG/DL. THEY TREATED HIM WITH GLUCAGON TABLETS AND INSULIN DRIP, AND THEN HE WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED WITH A 167MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86701 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization