BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4920187 · Received July 16, 2015

    Report

    Report Number
    3004209178-2015-74860
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE WAS AT 153 AFTER THEY WERE TREATED IN THE HOSPITAL. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ABOUT THE HOSPITALIZATION. THE CUSTOMER STATED THAT THEY FELT LOW IN BLOOD GLUCOSE AND RAN STRAIGHT INTO A TREE. THE CUSTOMER WAS SENT A REPLACEMENT INSULIN PUMP. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462531 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 45 YR Hospitalization