BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 7521801 · Received May 17, 2018

    Report

    Report Number
    3004209178-2018-72410
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    April 8, 2018
    Report Date
    May 17, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169782396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 18 MMOL/L AND 22 MMOL/L AND 25 MMOL/L. THE BLOOD GLUCOSE LEVEL WAS 22 MMOL/L AT THE TIME OF INCIDENT. THE CURRENT BLOOD GLUCOSE WAS 21.5 MMOL/L. CUSTOMER TREATED WITH INSULIN PUMP. THE PRODUCT WILL NOT RETURN FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366101 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG1T87S 00643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Other