BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240657 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49766
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 REPORTED THAT THE INSULIN PUMP RETURNED A NO DELIVERY ALARM WHICH WAS RESOLVED BY A SET CHANGE. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BEEN ERASING HER BASAL RATES FOR TWO WEEKS LEADING UP TO THE CALL. CUSTOMER REPORTED RECENTLY HAVING A HIGH BLOOD GLUCOSE LEVEL THAT THE INSULIN PUMP COULD NOT READ. CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 420 MG/DL THE DAY BEFORE THE CALL. CUSTOMER ALSO REPORTED RECEIVING TWO ADDITIONAL NO DELIVERY ALARMS WITHIN ONE MONTH OF THE CALL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723372 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR