BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121143 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93750
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE PARAMEDICS HAD BEEN CALLED TWICE SINCE THE EMERGENCY VISIT. TROUBLESHOOTING WAS PERFORMED, AND TIME/DATE AND BOLUS HISTORY WERE ACCURATE. THE CUSTOMER MENTIONED THAT THERE ARE AT LEAST 42.0 UNITS OF INSULIN IN THE RESERVOIR, BUT THE STATUS SCREEN IS INDICATING THAT THERE ARE 22.80 UNITS LEFT. FOUND ALL LOW BLOOD GLUCOSE WERE BECAUSE SHE OVERESTIMATED HER CARBOHYDRATES AND PROGRAMMED TOO MUCH INSULIN TO DELIVER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221753 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization