BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6166559 · Received December 12, 2016

    Report

    Report Number
    2032227-2016-49408
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL, SHE WAS HAVING SENSOR ISSUES, AS THE INSULIN PUMP CONTINUED TO ALARM SENSOR ERROR. THE CUSTOMER DIDN'T RECALL HER BLOOD GLUCOSE AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ADVISED TO REMOVE THE SENSOR. CUSTOMER STATE THE SENSOR LOOKED AS IT WAS MISSING A PIECE WAS BROKEN OFF. CUSTOMER WAS ADVISED TO REPLACE THE SENSOR AND RETURN THE BROKEN SENSOR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818681 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG118Y5

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR