BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3222934 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02850
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 16, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 12 MG/DL. CUSTOMER STATED THAT HE WAS FOUND UNCONSCIOUS ON THE FLOOR. THE PARAMEDICS WERE CALLED AND HE WAS TAKEN TO HOSPITAL VIA AMBULANCE. CUSTOMER WAS ADMITTED TO ICU, BLOOD GLUCOSE WILL NOT RISE. CUSTOMER TREATED WITH DEXTROSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323911 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization