BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMT-715 PARADIGM INSULIN PUMP

    MDR report key: 8883075 · Received August 12, 2019

    Report

    Report Number
    2032227-2019-45433
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    UDI-DI
    00613994473844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640 G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN PUMP STOPPED WORKING AND ACT AND DOWN ARROW BUTTON STOPPED WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 10.3 MMOL/L AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679592 MMT-715 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL B0715WWLJ 00613994473844

    Patients

    Seq Age Sex Outcome Treatment
    1