BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 7739568 · Received August 1, 2018

    Report

    Report Number
    3004209178-2018-98401
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    July 3, 2018
    Report Date
    August 1, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000090197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL WAS 48 MG/DL. CUSTOMER HAD ISSUE WITH SENSOR. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. CONCOMITANT PRODUCT: OZO- SENSOR-MMT-7008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582005 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2H8GY 00763000090197

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other