BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 5402799 · Received February 1, 2016

    Report

    Report Number
    3004209178-2016-84305
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 14, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD DAMAGE. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS UNKNOWN MG/DL. CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER FELL ON ICE TODAY AND DAMAGE THE LCD SCREEN. THE CUSTOMER'S MOTHER STATED THAT ALMOST NOTHING CAN BE READ FROM THE PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER INSULIN PUMP IS OOW CAN'T REPLACE IT. THE CUSTOMER AGREED TO SEND THE OOW LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61458 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1