BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974382 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89089
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS PROGRAMMED AND MONITORED FOR THREE DAYS WITH NO BLANK DISPLAY NOTED. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONED PROPERLY. THE INSULIN PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP. NO DAMAGE WAS NOTED ON THE ISOLATION TAPE. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND MOTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CAMP NURSE THAT THE CUSTOMER'S INSULIN PUMP GOT WET. SHE STATED THE SCREEN WAS GOING ON AND OFF. THE MOISTURE UNDER THE SCREEN MADE THE INSULIN PUMP GO BLANK. THE CUSTOMER IS CURRENTLY DISCONNECTED AND WAS REVERTED TO A BACK-UP PLAN. THE BLOOD GLUCOSE READING WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450529 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CMH

    Patients

    Seq Age Sex Outcome Treatment
    1