BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3081805 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92774
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO UNLOCKED KEYPAD CONNECTOR. NO FROZEN PUMP SCREEN NOTED. UNABLE TO VERIFY FOR TIME ANOMALY OR ALARM DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT INSULIN PUMP HAD A FROZEN DISPLAY. THERE WAS NO RESPONSE FROM THE BUTTONS. CUSTOMER'S BLOOD GLUCOSE READING WAS 101 MG/DL. THE SCREEN IS NOT TOTALLY BLANK. NO ALARMS DURING OR AFTER THE TIME THE BUTTONS WERE NOT RESPONDING. CUSTOMER STATES THE INSULIN PUMP WAS FROZEN WITH NO ADVANCEMENT OF TIME. ADVISED CUSTOMER THE INSULIN PUMP WILL BE REPLACED. NOTHING FUTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184023 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAS

    Patients

    Seq Age Sex Outcome Treatment
    1