BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 7230646 · Received January 31, 2018

    Report

    Report Number
    3004209178-2018-47351
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 21, 2018
    Report Date
    July 30, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    20643169646432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RANDOM SENSOR. WE PERFORMED CONTINUITY RESISTANCE TEST SENSOR PASSED PER SPECIFICATION. ALSO, PERFORMED BICARBONATE BUFFER TEST AND SENSOR FAILED PER SPECIFICATIONS DUE TO HIGH READINGS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 152, 167, 144 AND 125 MG/DL AND THE SENSOR GLUCOSE WAS 125, 59 AND 70 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 59 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 80 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76394 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7008A HG234BM 20643169646432

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR