BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974306 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05301
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 UNABLE TO CONFIRM ADHESIVE ANOMALY DUE TO SENSORS WERE RETURNED OPENED OR USED. UNABLE TO CONFIRM COMPLAINT DUE TO CUSTOMER RETURNING SENSORS WITH NO NEEDLES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF HER SENSORS STUCK TO HER BODY AND THE OTHER ONE CAUSED BLEEDING AT THE INSERTION SITE. THE BLOOD GLUCOSE READING WAS 214 MG/DL. THE CUSTOMER ALSO STATED THAT THE CANNULA WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450016 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG00ASN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR