BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3980863 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89863
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH AN INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS ANOMALY NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED BELT CLIP SLOT.

    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 THE NUMBERS ARE RAMPING OR THE SCROLL BAR IS MOVING UP AND DOWN WHEN NOTHING HAS BEEN INPUTTED ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 146 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456954 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1