BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 7199467 · Received January 17, 2018

    Report

    Report Number
    3004209178-2018-43739
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    January 6, 2018
    Report Date
    June 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    20643169646432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR AND PERFORMED CONTINUITY RESISTANCE TEST. SENSOR PASSED PER SPECIFICATION. ALSO, PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. SEE ATTACHED FILE FOR DETAILS. DATA ENTRY ERROR. ENTERED WRONG SVN (B)(4). CORRECT SVN IS (B)(4). ET. (B)(6) 2018.

    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

    CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 304MG/DL AND THE SENSOR GLUCOSE WAS 41MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER RECEIVED CHANGE SENSOR ALERT AFTER CALIBRATION ERROR. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46374 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7008A HG23Z79 20643169646432

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR