BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212015 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45056
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP WAS RECEIVED WITH CURRENTS IN SPEC. NO UNEXPECTED FAILED BATTERY OR BATTERY OUT LIMIT ALARMS NOTED. THE INSULIN PUMP WAS UNABLE TO COMPLETE THE PRIME TEST DUE TO CRACKED END CAP. NO FURTHER TESTING COULD BE COMPLETED DUE TO PRIME ANOMALY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BROKEN BELT CLIP SLOT, 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNRESPONSIVE BUTTONS ON HER KEYPAD WHEN SHE ATTEMPTED TO BOLUS. SHE ALSO REPORTED THE NUMBERS WERE RAMPING ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. 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
    693026 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR