BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4251902 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-53028
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    June 8, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE, DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO BUTTON ERROR ALARM OR UNEXPECTED NUMBERS RAMPING WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP, A BROKEN BELT CLIP SLOT, SCRATCHED RESERVOIR TUBE WINDOW, A STAINED END CAP STICKER, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM ON THE INSULIN PUMP, AFTER SHE WAS AT A PARK AND IT WAS HOT. THE CUSTOMER STATED THE NUMBERS WERE GOING UP. HER BLOOD GLUCOSE LEVEL WAS 143 MG/DL. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP TREATMENT PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736780 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR