BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230876 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-36689
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS MONITORED FOR 48 HOURS WITH MULTIPLE BASAL RATES, AND NO ANOMALIES WERE NOTED. THE PUMP PASSED THE SELF TEST, AND ALL OPERATING CURRENTS WERE NORMAL. NO DISPLAY ANOMALY WAS NOTED. NO UNEXPECTED LOW BATTERY, FAILED BATTERY TEST OR OFF NO POWER ALARMS NOTED. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S INSULIN PUMP SHUT OFF AFTER SHE HAD REPLACED THE BATTERY. CUSTOMER REPORTED RECEIVING A BATTERY FAILED TEST ALARM SHORTLY AFTER. CUSTOMER ALSO REPORTED A BLANK DISPLAY. SHE STATED THAT THE DISPLAY DOES NOT RETURN AFTER SHE INSERTED A NEW BATTERY. THE CUSTOMER ALSO STATED HER BATTERY COMPARTMENT WAS NOT DAMAGED OR CORRODED. CUSTOMER'S BLOOD GLUCOSE WAS 98 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712599 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR