BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2853759 · Received December 3, 2012

    Report

    Report Number
    2032227-2012-07908
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 18, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    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

    UNRESPONSIVE BUTTONS DUE TO MOISTURE DAMAGE ON KEYPAD TRACE. DISPLAY FUNCTIONS PROPERLY WITH TESTING CASE, NO FROZEN DISPLAY NOTED. UNABLE TO VERIFY THE BATTERY OUT LIMIT ALARM DUE TO KEYPAD DAMAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY. CUSTOMER STATED THAT THE TIME ON THE INSULIN PUMP IS NOT ADVANCING AND THERE IS NO RESPONSE FROM ANY BUTTON. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG LZG MEDTRONIC MINIMED MMT-512LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR