BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4210078 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44680
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 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

    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE HAS A HUGE HEMATOMA THAT IS THE SIZE OF HIS FIST. HIS DOCTOR TOLD HIM THAT HE MOST LIKELY HIT A VEIN BECAUSE THERE WAS SO MUCH BLOOD. CUSTOMER'S BLOOD GLUCOSE READING WAS 122 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693912 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F264U

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR