BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4141787 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33600
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP 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

    CUSTOMER REPORTED RECEIVING CALIBRATION ERRORS, SENSOR ERRORS, AND LOST SENSOR ALARMS ON HIS INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 46 MG/DL. THE CUSTOMER TREATED HIS LOW BLOOD GLUCOSE AND DECLINED TO TROUBLESHOOT FOR HIS BLOOD GLUCOSE. TROUBLESHOOTING FOR THE LOST SENSOR ALARM FOUND THE INSULIN PUMP WAS COMMUNICATING WITH THE TRANSMITTER. THE CUSTOMER WAS ADVISED THAT HIS ALERTS MAY BE CAUSED BY THE SENSORS PULLING OUT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621434 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E084U

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR