BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 8358348 · Received February 21, 2019

    Report

    Report Number
    3004209178-2019-58382
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 17, 2019
    Report Date
    February 21, 2019
    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

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND HAD HIGH BLOOD GLUCOSE LEVELS RANGED FROM 22 MMOL/L TO 23 MMOL/L. IT WAS REPORTED THAT THE CUSTOMER TREATED WITH MANUAL INJECTIONS. IT WAS REPORTED THAT THE BLOOD GLUCOSE LEVEL FROM REPORTED EVENT WAS 6 MMOL/L TO 7 MMOL/L AND THE SUGAR GLUCOSE WAS 22 MMOL/L TO 23MMOL/L . TROUBLESHOOTING WAS NOT PERFORMED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153547 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG2S4NX 00643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Other