BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4151590 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34661
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 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
    PA
    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. 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

    NO BUTTON ERROR ALARM NOTED. THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACE. NO FURTHER TESTS COULD BE PERFORMED DUE TO UNRESPONSIVE BUTTON. NO FROZEN SCREEN DURING TESTING NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 227 MG/DL. CUSTOMER STATED THAT THE SCREEN WAS FROZEN AND WHEN THE CUSTOMER TOOK OUT THE BATTERY THERE WAS A BATT OUT LIMIT ALARM. CUSTOMER COULD NOT CLEAR THE ALARM AND CANNOT USE THE ESC BUTTON AT ALL. 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 TROUBLESHOOTING OTHER ISSUES WITH THE PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633515 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR