BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4151586 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34652
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED ESCAPE, ACT, UP AND DOWN BUTTONS ON THE KEYPAD TRACE. NO BUTTON ERROR ALARM DURING OUR TESTING. NO MOISTURE DAMAGE ON ELECTRONIC, MOTOR, VIBRATOR AND BATTERY TUBE ASSEMBLY DURING VISUAL INSPECTION. THE INSULIN PUMP HAS MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 125 MG/DL. CUSTOMER STATED THAT THE PUMP WAS EXPOSED TO MOISTURE THROUGH THE RAIN. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. CUSTOMER DECLINED TO RETURN THE INSULIN PUMP AND UNDERSTANDS THAT HE WILL BE LIABLE FOR THE PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633129 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR