BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4133342 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31340
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.(B)(4)

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO UP OR DOWN ARROW BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BATTERY OUT LIMIT ALARM COULD BE VERIFIED DUE TO THE UNRESPONSIVE BUTTONS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW AT THE BOTTOM LEFT AND RIGHT SIDE, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR THE RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND A CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP HAD A BUTTON ERROR WHEN PROGRAMMING A BOLUS DELIVERY. THE BUTTONS ARE NOT WORKING. CUSTOMER'S BLOOD GLUCOSE WAS 129 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. IT WAS ALSO REPORTED THAT THE DEVICE ALARMED BATTERY OUT LIMIT AFTER THE BATTERY WAS CHANGED. THE ALARM WAS EXPLAINED TO CUSTOMER, WHO STATED IT WAS IMPOSSIBLE FOR THE ALARM TO OCCUR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610778 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1