BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3981992 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05427
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE ON KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING TESTING. ALL BUTTONS FUNCTIONED PROPERLY. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON 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 CUSTOMERS FATHER CALLED STATING BUTTONS ON INSULIN PUMP WERE NOT FUNCTIONING PROPERLY. HE STATES THE RESERVOIR PORTION OF THE INSULIN PUMP HAD A CRACK AND SHOWED MOISTURE. HE STATES THAT CUSTOMER RECEIVED AND ERROR ALARM WHEN REWIND WAS ATTEMPTED. NO BLOOD GLUCOSE WAS REPORTED. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458485 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1