BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4211944 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45363
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    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

    RELIABILITY ANALYSIS INSPECTED THREE OPENED/USED ENLITE SENSOR AND PERFORMED TESTING. TWO OF THREE SENSORS FAILED WITH LOW READINGS. THE REMAINING SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 39 MG/DL. THE CUSTOMER STATED THAT HE TREATED HIMSELF OFF HIS SENSOR'S REPORTED BLOOD GLUCOSE VALUES AND THAT COULD HAVE CAUSED HIS LOW BLOOD GLUCOSE LEVEL. HIS SENSOR WAS READING 45 TO 70 POINTS OFF THE REAL BLOOD GLUCOSE VALUE. TROUBLESHOOTING WAS DECLINED. THE PRODUCT IS BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693762 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A D164U

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other