BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945788 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87949
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSERTION. NO BLANK DISPLAY NOTED. INSULIN PUMP ALARMED FAILED BATTERY TEST AFTER BATTERY INSERTION DUE TO CORRODED BATTERY TUBE. INSULIN PUMP UNABLE TO TEST THE OPERATING CURRENTS, LOW BATTERY ALARM AND OFF NO POWER ALARM DUE TO FAILED BATTERY TEST ALARM. INSULIN PUMP HAD A MINOR SCRATCH ON DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP. NO DAMAGE NOTED ON CONNECTOR ISOLATION TAPE ON LCD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP SHUT OFF BY ITSELF AND ALSO RECEIVED A FAILED BATTERY ALERT. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 375 MG/DL AND HAS TREATED WITH A MANUAL INJECTION. CUSTOMER REPORTED HAVING CHANGED THE BATTERIES SEVERAL TIMES AND THE INSULIN PUMP STILL DOES NOT POWER UP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425273 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR