BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972086 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05107
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 HIS INSULIN PUMP IS HAVING ISSUES. HE STATED HIS BLOOD GLUCOSE WAS HIGH AND HE WAS GIVING A BOLUS. HIS BLOOD GLUCOSE WAS 140 MG/DL. SEVERAL MONTHS AGO, HE HAD A HIGH OF 260 MG/DL. HE STATES HE HAD HIGH AROUND (B)(6) 2014, WHEN USING THE DEVICE. CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP FOR AWHILE. THE DEVICE'S HISTORY SHOWED SEVERAL ALARMS. A TEMPORARY BASAL WAS NOT PROGRAMMED BEFORE THE ALARM. CUSTOMER CHANGED THE BATTERY, AND AFTERWARDS THE DEVICE ALARMED. THE DEVICE WAS NOT STORED FOR A LONG TIME. CUSTOMER WAS ADVISED THE DEVICE EXPERIENCED AN UNEXPECTED RESTART. HE WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK IF THE ISSUE RECURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447158 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR