BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4151609 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34646
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT WORKING ANYMORE. CUSTOMER WANTED TO KNOW HOW TO GET ANOTHER INSULIN PUMP. CUSTOMER STATED THAT HE HAS BEEN OFF THE PUMP FOR A YEAR AND HAS BEEN USING THE NEEDLE. CUSTOMER STATED THAT THE SCREEN WILL GO BLACK AND THEN SHUT OFF. CUSTOMER NOTICED THE LITTLE PIECE OF THE PUMP WAS STICKING OUT AND HE PUSHED IT IN. THE CUSTOMER WORE IT LIKE THIS UNTIL IT STOPPED WORKING. CUSTOMER STATED THAT THE PLUG IS IN AND IT IS IN ALL THE WAY. CUSTOMER CONFIRMED THAT IT WAS THE OPPOSITE END OF THE RESERVOIR. CUSTOMER REPORTED THAT HE REMOVES THE PUMP BEFORE SHOWERING. SINCE THE DRIVE SUPPORT CAP WAS PROTRUDED, THE PUMP WOULD NEED TO BE REPLACED, AND THE BLANK DISPLAY TROUBLESHOOTING WILL HELP ANALYSIS WHEN PUMP IS RECEIVED BY MEDTRONIC. CUSTOMER WOULD LIKE TO HAVE HIS WIFE CALL BACK TO ASK ABOUT THE LOANER PUMP POLICY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633142 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR