BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4240594 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49773
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 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. PLEASE SEE MEDWATCH REPORT 2032227-2014-49651.

    Additional Manufacturer Narrative · 1

    FOUR OPENED AND USED SENSORS WERE INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. ONE OF FOUR FAILED DUE TO HIGH READINGS. THE THREE REMAINING SENSORS PASSED PER SPECIFICATION WITH ACCURATE READINGS. THE INTRODUCER NEEDLES WERE CHECKED FOR BURRS AND HOOKS AND DULL NEEDLE TIP DEFECTS AND NONE WERE FOUND. THREE NEEDLES WERE MISSING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE RECEIVED SENSOR END ALERT AND HER INSULIN PUMP WENT TO THRESHOLD SUSPEND. AT THE TIME, HER SENSOR READ 63 MG/DL AND WENT UP TO 138 MG/DL, BUT HER BLOOD GLUCOSE WAS 272 MG/DL. THE CUSTOMER STATED THAT SHE GOT LOW PREDICTED ALARM AND SENSOR GLUCOSE READING WAS 206 MG/DL AND BLOOD GLUCOSE WAS 640 MG/DL. SHE PULLED OUT THE SENSOR TURNED OFF THE INSULIN PUMP. CUSTOMER TURNED THE INSULIN PUMP BACK ON AND RECEIVED THE SENSOR END ALERT. THE CUSTOMER ALSO REPORTED BLOOD AT THE INSERTION SITE. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER CONFIRMED THAT BLEEDING HAD STOPPED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723777 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E214U

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR