BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103671 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25404
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING OUR TESTING. NO MOISTURE DAMAGE INSIDE PUMP NOTED. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 13.7 MMOL/L. NO SIGNIFICANT EVENTS LEADING UP TO THE ALARM WERE RECALLED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582138 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754CAS

    Patients

    Seq Age Sex Outcome Treatment
    1