BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150330 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35046
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 REPORTS THAT INSULIN PUMP IS FALSELY SHOWING RESERVOIR EMPTY. CUSTOMER ALSO STATES SHE HAS RECEIVED A NO DELIVERY ALARM AND BATTERY OUT LIMIT ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 217 MG/DL. CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE AND BLOOD GLUCOSE DROPPED TO 49 MG/DL WHICH CUSTOMER TREATED WITH FOOD. CUSTOMER WAS ADVISED THAT INFUSION SETS AND RESERVOIRS WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629810 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR