BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMT-712 PARADIGM INSULIN PUMP

    MDR report key: 8783925 · Received July 12, 2019

    Report

    Report Number
    2032227-2019-28935
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    UDI-DI
    00613994469694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE INSULIN PUMP HAD UP AND DOWN KEYS WEAR NOT SENSITIVE AND KEYPAD ISSUE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580699 MMT-712 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712EWS A4712EWSJ 00613994469694

    Patients

    Seq Age Sex Outcome Treatment
    1