BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942782 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04272
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) ANALYSIS INSPECTED 1 OPENED OR USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST PER (B)(4). THE SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. WE WERE UNABLE TO CONFIRM THAT THE CUSTOMER RECEIVED THE SENSOR IN THE SAID CONDITION BECAUSE THE UNIT WAS RETURNED OPENED OR USED. ALSO FOUND A BENT CANNULA.

    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 THE INSULIN PUMP KEPT GOING INTO THRESHOLD SUSPEND AND BLOOD GLUCOSE LEVEL WAS NOT LOW. TROUBLESHOOTING PERFORMED. BLOOD GLUCOSE WAS 214 MG/DL AND SENSOR GLUCOSE LEVEL 65 MG/DL, 69.6 PERCENT DIFFERENCE. CARELINK DATA WAS AVAILABLE. ONE METER USED. CALIBRATION FACTOR IS ABOVE THE OPTIMAL LEVEL. JAGGED TRACES NOTED. CALIBRATION FACTOR TRENDING UPWARD AND ISIG IS TRENDING DOWNWARD. THE SENSOR WAS REMOVED AND IT WAS A LITTLE BENT ADVISED IT COULD HAVE BENT DUE TO MOVEMENT. THE SENSOR WAS READING CORRECTLY WHEN FIRST INSERTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419854 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR