BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123037 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29582
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST AND SELF TEST. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE LOW BATTERY ALARM AND OFF NO POWER ALARM FUNCTIONED PROPERLY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP WAS PROGRAMMED AND MONITORED FOR SIX DAYS WITH NO UNEXPECTED BLANK DISPLAY NOTED. NO DATA WAS AVAILABLE DUE TO THE INSULIN PUMP BEING RECEIVED WITHOUT A BATTERY INSTALLED. THE BATTERY TUBE CONNECTOR WAS LOCKED PROPERLY ON THE INTERFACE BOARD. NO DAMAGE WAS NOTED ON THE ISOLATION TAPE. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC ASSEMBLY OR MOTOR. NO ANOMALY WAS NOTED WHEN INSPECTING THE ELECTRONIC ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP STOPPED WORKING, THREE HOURS DURING THE NIGHT, WITHOUT ALARMING. CUSTOMER DID NOT KNOW BLOOD GLUCOSE VALUE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600444 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1