BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOCUMENT PACKAGE/GSG (670G PUMP)

    MDR report key: 8590010 · Received May 8, 2019

    Report

    Report Number
    2032227-2019-03938
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION WAS INCORRECT WITH THE INITIAL REPORT. THE CORRECT INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    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 HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER DID EXPERIENCED THE SYMPTOMS SUCH AS POSITIVE RESULTS IN KETONE TEST ,NAUSEA ,VOMITING, ABDOMINAL PAIN AND DIFFICULTY BREATHING. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386537 DOCUMENT PACKAGE/GSG (670G PUMP) OZP MEDTRONIC MINIMED MMT-1728EN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other FRN-UNK-RSVR, UNOMED INF SET