BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 5782344 · Received July 11, 2016

    Report

    Report Number
    2032227-2016-13666
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 20, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K031390
    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 PATIENT INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 150 MG/DL. CUSTOMER'S MOTHER STATED THAT ALL OF THE BUTTONS STOPPED WORK. CUSTOMER WAS ADVISED THAT PUMP IS OOW AND AGREED TO SEND THE OOW LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438047 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-712LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1