BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2810335 · Received October 31, 2012

    Report

    Report Number
    2032227-2012-07597
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARMED DURING REWIND DUE TO CORROSION ON MOTOR HOME SWITCH. CORROSION FOUND ON TRANSDUCER AND INTERFACE BOARD. UNABLE TO VERIFY SEVERAL MOTOR ERROR ALARMS DUE TO MOTOR DAMAGE. KEYPAD BUTTON AND DISPLAY FUNCTION PROPERLY. NO FROZEN DISPLAY OR DAMAGE FOUND ON KEYPAD TRACE.

    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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FROZEN DISPLAY AND UNRESPONSIVE BUTTONS ON THE INSULIN PUMP. THE CUSTOMER STATED THAT THE TIME ON THE SCREEN WAS NOT ADVANCING EITHER. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NOT RESOLVED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR