BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAP

    MDR report key: 8622900 · Received May 20, 2019

    Report

    Report Number
    3004209178-2019-99265
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 20, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169404335
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    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. 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNSPECIFIED PUMP ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN TA THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417464 530G INSULIN PUMP MMT-751NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP A2751NAPJ 00643169404335

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR