BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972037 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05047
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 14, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO MOISTURE-DAMAGED KEYPAD TRACES. THE UNIT HAD A SCRATCHED DISPLAY WINDOW, A SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOWN ARROW BUTTON ON THE CUSTOMER'S INSULIN PUMP WAS NOT WORKING PROPERLY. THE CUSTOMER STATED THAT THE BUTTON WOULD NO LONGER DEPRESS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447115 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1