BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4181077 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-20023
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 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

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO CORRODED BATTERY TUBE. THE OPERATING CURRENTS COULD NOT BE MEASURED AND NO KEYPAD FUNCTION COULD BE TESTED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP, AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A BLANK DISPLAY ON THEIR INSULIN PUMP. IT WAS ALSO REPORTED THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER HAD REPLACED THE BATTERIES BUT THE BLANK DISPLAY PERSISTS. THE CUSTOMER ALSO REPORTED THERE WAS CORROSION ON THE BATTERY COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE WAS 14 MMOL/L. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661684 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAB

    Patients

    Seq Age Sex Outcome Treatment
    1