BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3972340 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05160
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OPENED AND USED SENSORS WERE INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. ONE OF THE TWO SENSORS FAILED FOR HIGH READINGS AND THE OTHER PASSED PER SPECIFICATION WITH ACCURATE 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING HE HAS BEEN GETTING MULTIPLE SENSOR ERRORS FOR THE LAST DAY AND A HALF. THIS IS UNIQUE TO THIS BOX OF SENSORS. HIS BLOOD GLUCOSE IS 43 MG/DL. HE STATED IT WAS LOW BECAUSE HE WAS NOT ALARMED BY HIS SENSOR. HE HAS TREATED BY EATING. HE DECLINED TROUBLE SHOOTING FOR LOW BLOOD GLUCOSE. THE TRANSMITTER PASSED THE TEST PLUG PROCEDURE. THE SENSOR FEATURE IS TURNED ON. THE SENSOR APPEARS TO BE FULLY INSERTED. THE LOST SENSOR ERROR OCCURRED AFTER INITIALIZATION. RADIO FREQUENCY WAS ESTABLISHED. CUSTOMER WAS CONVINCED THE ISSUE IS WITH THE PRODUCT, AND NOT THE ENVIRONMENT. CUSTOMER CALLED BACK ON (B)(6) 2014, STATING THERE ARE LARGE DISCREPANCIES BETWEEN HIS SENSOR READINGS AND BLOOD GLUCOSE LEVELS. THE SENSORS READ 86 MG/DL, BUT HIS BLOOD GLUCOSE IS 130 MG/DL. THE SENSOR GLUCOSE GRAPH IS TRENDING IN THE SAME DIRECTION AS BLOOD GLUCOSE. CUSTOMER SOMETIMES TREATS BASED IN THE SENSOR READINGS. HE WAS ADVISED AGAINST USING THE SENSOR TO TREAT. CUSTOMER HUNG UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448259 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C314U

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention