BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3984354 · Received August 6, 2014

    Report

    Report Number
    2032227-2014-05991
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP RECEIVED WITH CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP. INSULIN PUMP RECEIVED WITH UPDATED SOFTWARE CONFIGURATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BUTTONS ON THE INSULIN PUMP ARE NOT RESPONDING. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NOT RECORDED. PUMP HAS BEEN REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461848 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1