BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972470 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88759
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS FAILING. THE CUSTOMER WAS IN SCHOOL, THEY TRIED TO DELIVER A BOLUS, WAS GOING TO INPUT THE BLOOD GLUCOSE VALUES IN THE INSULIN PUMP, BUT THE KEYPAD WOULD NOT GO PAST 54 MG/DL. THE INSULIN PUMP WOULD NOT RESPOND AND THE DEVICE KEPT FLASHING THE SAME NUMBER. THEY WERE ADVISED TO REMOVE THE BATTERY AND PUT IN A NEW BATTERY, BUT THE DEVICE STILL DID NOT RESPOND. THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. THE CALLER STATED THAT THE INSULIN PUMP CAME OFF OF THE BELT CLIP ONCE BUT IT WAS JUST HANGING BY THE CUSTOMER'S SIDE, AND THE DEVICE WAS FINE. THE CALLER STATED THAT THE CUSTOMER HAD GONE INTO THE WATER BUT HAS ALWAYS TAKEN THE DEVICE OFF BEFORE ENTERING THE WATER. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449719 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754DAH

    Patients

    Seq Age Sex Outcome Treatment
    1