BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4163536 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36405
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO BATTERY OUT LIMIT ALARM NOTED. THE DEVICE WAS RECEIVED INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS ANOMALY NOTED. THE DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, AND CRACKED RESERVOIR TUBE LIP.

    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

    CUSTOMER REPORTED THAT THE NUMBERS ON THE INSULIN PUMP'S SCREEN BEGAN TO RAMP DURING BOLUS. CUSTOMER REPLACED THE BATTERY THEN RECEIVED A BATTERY OUT LIMIT. CUSTOMER ALSO REPORTED THAT NONE OF THE BUTTONS ON THE KEYPAD WERE RESPONDING. BLOOD GLUCOSE LEVEL WAS 234 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640663 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCMP

    Patients

    Seq Age Sex Outcome Treatment
    1