BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942795 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04460
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    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 HE WENT OUT OF TOWN AND DID NOT TAKE THE INSULIN PUMP. WAS TRYING TO GET BACK ON THE DEVICE NOTED IT WAS OFF. CHANGED BATTERY AND THE DEVICE ALERTED BATTERY LIMIT OUT, INFORMED WHY ALARM OCCURRED. CLEARED ALARM AND REPROGRAMMED TIME AND DATE. THE DEVICE THEN ALARMED LOW RESERVOIR. CUSTOMER WAS EXPLAINED THE DEVICE MIGHT HAVE BEEN ALARMING WHILE HE WAS OUT OF TOWN WHICH COULD HAVE CAUSED THE DEVICE TO LOSE BATTERY POWER. BLOOD GLUCOSE LEVEL WAS 155 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419596 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR