BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3812883 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02354
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    INSULIN PUMP RECEIVED WITH A FROZEN DISPLAY AND A CONSTANT TONE DUE TO A FAULTY INTERFACE BOARD. UNABLE TO VERIFY BLACK DOT ON THE DISPLAY AND BUTTONS UNRESPONSIVE DUE TO FROZEN DISPLAY AND CONSTANT TONE. CRACKS TO THE CASE, RESERVOIR TUBE LIP, BATTERY TUBE THREADS AND A SCRATCHED LCD WINDOW ALSO NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY, 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
    291148 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR