BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103501 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26510
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED ENLITE SENSOR AND PERFORMED TESTING. THE SENSOR FAILED PER SPECIFICATION WITH LOW READINGS. ALSO, FOUND CANNULA BENT. UNABLE TO CONFIRM THAT CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO PRODUCT BEING RETURNED OPENED/USED.

    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 THAT THE SENSORS GAVE INACCURATE READINGS. THE SENSOR READING WAS 42 MG/DL WHEN THE BLOOD GLUCOSE READING WAS 204 MG/DL. SHE REPORTED THAT SHE RECEIVES INAPPROPRIATE THRESHOLD SUSPEND ALARMS THROUGH THE NIGHT. SHE STATED THAT THE SENSOR CANNULA LOOKED BENT. SHE WAS ADVISED ON INSERTION PROTOCOL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584884 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B284U

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR