BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3972089 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05115
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING ISSUES WITH HIS LAST TWO SENSORS. HE CAN'T GET THEM TO LINK TO HIS INSULIN PUMP. HIS BLOOD GLUCOSE WAS 106 MG/DL. THE FIRST SENSOR SAID SENSOR ERROR, THE SECOND ONE SAID LOST SENSOR. THE CORRECT TRANSMITTER ID WAS PROGRAMMED. HE WAS ADVISED OF A POSSIBLE WETTING ISSUE. THE SENSOR IS BRAND NEW. IT IS INSERTED IN THE ABDOMEN AREA. THE LOST SENSOR ALERT OCCURRED DURING INITIALIZATION. RADIO FREQUENCY COMMUNICATION WAS NEVER ESTABLISHED. CUSTOMER CALLED BACK AN HOUR LATER, REPORTING THE SAME SENSOR ISSUES. HE STATED THAT HE TOOK TOO MUCH INSULIN AND HIS BLOOD GLUCOSE DROPPED TO 50 MG/DL. HE TREATED WITH GLUCOSE TABLETS. WHEN HE PULLED OUT THE SENSOR, IT WAS STRAIGHT. WHEN TESTING THE TRANSMITTER, IT WAS NOT WORKING. CUSTOMER RETURNED TWO SENSORS FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447159 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B254U

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention