BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984125 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91480
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 1000MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE INSULIN PUMP CONTINUED ALARMING NO DELIVERY EVEN AFTER THE INFUSION SETS WERE CHANGED. THE CUSTOMER MENTIONED THAT SOMETIMES SHE REFILLS THE RESERVOIRS. ADVISED THE CALLER THAT IT IS NOT RECOMMENDED TO REFILL THE RESERVOIRS. THE CUSTOMER STATED THAT SHE REMEMBERS WALKING INTO A WALL, AND THEN WAKING UP THREE DAYS LATER IN THE HOSPITAL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85827 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 51 YR Hospitalization