BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170398 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37518
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    UNIT RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. NO UNEXPECTED LOW BATTERY ALARMS NOTED. HOWEVER, UNIT ALARMED UNEXPECTED WEAK BATTERY AND FAILED BATTERY TEST WERE NOTED DUE TO FAULTY BATTERY TUBE. UNIT FUNCTIONED PROPERLY AFTER UNPLUGGING AND PLUGGING THE BATTERY TUBE CONNECTOR INTO B1 I/B. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND RESERVOIR TUBE LIP. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 254 MG/DL. THE CUSTOMER REPORTED A WEAK BATTERY ALARM FROM THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. A NEW BATTERY CAP FOR THE INSULIN PUMP WOULD BE SHIPPED. THE CUSTOMER REPORTED THAT THE NEW BATTERY CAP FOR THE INSULIN DID NOT RESOLVE THE ISSUE FOR THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651233 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR