BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3864626 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-03039
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO SLIGHTLY LOOSE DRIVE SUPPORT DISK. NO PRIME ALARMS WERE NOTED. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO MOISTURE DAMAGE AT KEYPAD TRACES. NO BUTTON ERROR OR FROZEN SCREENS WERE NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE AND BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, MISSING END CAP STICKER, RESERVOIR TUBE O-RING AND BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING, BUTTONS WERE NOT RESPONDING AND THE SCREEN WAS FROZEN. CALLER STATED THAT THE CUSTOMER WAS NOT ABLE TO SCROLL DOWN TO THE MAIN MENU AND THE DRIVE SUPPORT CAP IS FLUSH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339207 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1