BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930826 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03576
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 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

    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

    ALL BUTTONS FUNCTION PROPERLY, HOWEVER MOISTURE DAMAGE WAS FOUND ON KEYPAD TRACES. NO RAMPING NUMBERS ON THEIR OWN OR SCROLLING BAR MOVING ANOMALY NOTED. ALL OPERATING CURRENTS ARE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY, OFF NO POWER OR WEAK BATTERY ALARM NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP IS NOT WORKING PROPERLY. THE INSULIN PUMP STARTED TO SCROLL AND ALARMED WEAK BATTERY. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. THE BLOOD GLUCOSE READING IS 211 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408673 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR