BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2965182 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-91116
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH LOOSE DRIVE SUPPORT DISK, MISSING END CAP STICKER, AND CRACKED CASE AT THE DISPLAY WINDOW CORNERS. ALL THE BUTTONS WORK PROPERLY. HOWEVER, MOISTURE DAMAGE NOTED ON THE KEYPAD TRACES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BOTTOM OF THE INSULIN PUMP IS OFF. THE CUSTOMER MENTIONED BEING SICK WITH A VIRUS AND HER BLOOD GLUCOSE HAS BEEN FLUCTUATING FROM 80 TO 350MG/DL. THE CALLER STATED THAT THE BACK OF THE PISTON WAS PUSHED OUT, AND SHE HAS TO PUSHED BACK IN ORDER TO HAVE THE DEVICE WORKING PROPERLY. THE CUSTOMER MENTIONED THAT THE DEVICE WAS DROPPED FOUR YEARS AGO AND THE DISPLAY GLASS HAD A SMALL CRACK. THE CUSTOMER ALSO REPORTED HAVING MOTOR ERROR AND BATTERY ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66854 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR