BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRN-MMT-332A,UNOMED-MMT-943,OZP-MMT-7020A

    MDR report key: 10389134 · Received August 10, 2020

    Report

    Report Number
    2032227-2020-160529
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 2, 2020
    Report Date
    August 10, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 499 MG/DL. CUSTOMER HAD HIGH KETONE WITH HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852701 FRN-MMT-332A,UNOMED-MMT-943,OZP-MMT-7020A PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FRN-MMT332A, UNOMED-MMT943, OZP-MMT7020A.