BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4132515 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-28446
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED ENLITE SENSOR, SHOW THAT THE SENSOR FAILED PER SPECIFICATIONS DUE TO HIGH READINGS.

    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-31023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR WAS GIVING LOW GLUCOSE READINGS WHILE HER BLOOD GLUCOSE WAS NOT LOW. THIS CAUSED THE INSULIN PUMP TO GO INTO A THRESHOLD SUSPEND ALARM STATE. THE CUSTOMER'S BLOOD GLUCOSE WAS 104 MG/DL, BUT THE SENSOR WAS SHOWING 56 MG/DL. THE CUSTOMER STATED SHE HAD ONE BENT SENSOR AND WAS HAVING TROUBLE WITH THE INSERTER. TROUBLESHOOTING WAS PERFORMED AND BEST INSERTION AND CALIBRATION PRACTICES WERE EXPLAINED TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610580 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C074U

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR