BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4190491 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41245
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K001829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUTTON WAS NOT RESPONDING ON THE CUSTOMER'S INSULIN PUMP. THE INSULIN PUMP REPORTEDLY WAS NOT BUMPED, DROPPED, OR EXPOSED TO MOISTURE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 490 MG/DL. THE CUSTOMER HAD VISITED THE DOCTOR FOR A BACK-UP PLAN AND INSULIN PEN. THE CUSTOMER WAS INSTRUCTED TO CONTACT THE DOCTOR FOR FURTHER TREATMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666925 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-511LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1