BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4862424 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19909
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESCRIPTION OF THE EVENT PROBLEM PROVIDED IN THE INITIAL REPORT WAS INCOMPLETE. THE ADDITIONAL INFORMATION WILL BE PROVIDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED RESERVOIR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM SENSOR CHANGE AND CALIBRATION ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 212 MG/DL. THE CUSTOMER STATED THAT BAD SENSOR ALERT OCCURRED AFTER A 2ND CONSECUTIVE CALIBRATION ERROR. CUSTOMER WAS ADVISED THE TIMING OD CALIBRATIONS LEADING TO ALERT AND CALIBRATION PROTOCOL. THE CUSTOMER WAS ADVISED TO REMOVED AND CHANGE OUT THE SENSOR. CUSTOMER WAS ADVISED THAT SENSOR WOULD BE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND WITH A BLOOD GLUCOSE LEVEL OF 212 MG/DL AND A SENSOR GLUCOSE LEVEL OF 40 MG/DL. THE CUSTOMER WAS ADVISED THAT THE SENSOR WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407032 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR