BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103688 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25406
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWER UP PROPERLY AFTER BATTERY INSTALLATION AND ALL OPERATING CURRENTS WERE WITHIN SPECIFICATIONS, NO FAILED BATTERY TEST ALARMS NOTED. UNIT RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHED DISPLAY WINDOW.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS WERE NOT RESPONDING ON THE CUSTOMER'S INSULIN PUMP AND MULTIPLE FAILED BATTERY TEST NOTIFICATIONS WERE RECEIVED. IT WAS STATED THAT THE BATTERY WAS REMOVED AND THE INSULIN PUMP WOULD NOT LOAD BACK UP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 5.6 MMOL/L. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581662 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1