BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4252173 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52868
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SENSOR HAD SENSOR ERROR, CHANGE SENSOR, CALIBRATION ERROR, SENSOR GLUCOSE AND BLOOD GLUCOSE READING DISCREPANCY AND THRESHOLD SUSPEND HAPPENED. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 158 MG/DL. CUSTOMER STATED INSULIN PUMP ALARMED LOW THRESHOLD SUSPEND AT 40MG/DL AND BLOOD GLUCOSE WAS 158 MG/DL. CUSTOMER CHANGED SENSOR AND GOT CALIBRATION ERROR AND CHANGED SENSOR. ADVISED THE CUSTOMER THE SENSORS WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736277 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG09898

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR