BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 7785475 · Received August 15, 2018

    Report

    Report Number
    2032227-2018-13362
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    July 15, 2018
    Report Date
    August 15, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM AS WELL AS MULTIPLE PUMP ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 95 AND 257 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL AT THE TIME OF THE INCIDENT. THE OTHER RELEVANT BLOOD GLUCOSE VALUES WERE 125, 160, 145 AND 90 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT 40 MG/DL. THRESHOLD SUSPEND LIMIT IN SENSOR SETTINGS 70 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. TROUBLESHOOTING WAS PERFORMED FOR PUMP ERROR ALARM AND THE CUSTOMER STATES THEY ARE ABLE TO REWIND THE PUMP. THE CUSTOMER PERFORMED DISPLACEMENT AND SELF-TEST AND IT PASSED THE TEST. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628217 SENSOR MMT-7020A ENLITE3 5PK US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other