BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4952762 · Received July 30, 2015

    Report

    Report Number
    3004209178-2015-79101
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 5, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE UNKNOWN MG/DL. THE CUSTOMER WAS ADVISED THAT HE WE WOULD SEND BATTERY CAP RIGHT AWAY. THE CUSTOMER WAS ADVISED TO CALL BACK IF SHE GETS BLANK DISPLAY EVEN AFTER YOU HAVE THE REPLACEMENT BATTERY CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498434 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554LWWH

    Patients

    Seq Age Sex Outcome Treatment
    1