BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123492 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29635
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    INSULIN POWER UP PROPERLY AFTER BATTERY INSTALLATION. INSULIN PUMP RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES WERE NOTED. NO DAMAGE ON THE CONNECTOR LCD ISOLATION TAPE NOTED. THE BATTERY CAP CONTACT RECEIVED CORRODED. NO TRACES OF MOISTURE WERE FOUND AT THE ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP STOPPED FUNCTIONING WITH NO POWER. THE BATTERY WAS REPLACED AND THE DEVICE FUNCTIONED AT FIRST THEN THE ISSUE RECURRED. CUSTOMER'S FATHER THING THE CUSTOMER MIGHT HAVE FALLEN IN THE POOL. CUSTOMER'S FATHER STATED THE DEVICE ALSO HAD A RAINBOW HUE IN THE DISPLAY. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602356 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754CMB

    Patients

    Seq Age Sex Outcome Treatment
    1