BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945884 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04749
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    August 17, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE RANDOM OPENED/USED SENSOR AND PERFORMED CONTINUITY RESISTANCE TEST. THE SENSOR FAILED PER SPECIFICATIONS. ALSO FOUND CANNULA BENT. UNABLE TO CONFIRM THAT THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITION DUE TO THE 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 RETURN 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 HER BLOOD GLUCOSE WAS 256 MG/DL. CUSTOMER STATED THAT SHE WAS HAVING PROBLEMS WITH HER SENSOR, IT WAS ALARMING SENSOR ERROR. CUSTOMER STATED THAT SHE PULLED IT OUT AND A PIECE WAS LEFT IN HER BODY. ADVISED TO ATTEMPT TO REMOVE THE REMAINING OF THE CANNULA, OR SEEK MEDICAL ATTENTION TO REMOVED IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425904 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR