BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974368 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05502
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 9, 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
    IL
    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

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR FAILED FOR LOW READINGS. NO NEEDLE COMPLAINT COULD BE CONFIRMED DUE TO THE NEEDLE NOT BEING RETURNED. THE CANNULA WAS FOUND BENT. IT COULD NOT BE CONFIRMED THAT THE SENSOR WAS RETURNED BENT DUE TO THE SENSOR BEING RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP KEPT ALARMED SENSOR ERROR. SHE ALSO STATED THAT WHEN SHE INSERTED THE SENSOR SHE HAD A LOT OF BLEEDING. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS 190 MG/DL. SENSOR WAS INSERTED AT 9 PM; IT'S BEEN INSERTED FOR 11 HOURS. ALARM OCCURRED AFTER INITIALIZATION. SENSOR APPEARS TO BE FULLY INSERTED AND FLAT AGAINST THE SKIN. CUSTOMER WAS ADVISED TO DISCONNECT. CUSTOMER WAS ADVISED TO INSPECT THE TRANSMITTER, IT ALSO PASSED TEST PLUG TEST. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451216 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR