BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933505 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03815
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST. SENSOR FAILED PER SPECIFICATIONS, DUE TO HIGH READINGS. ALSO FOUND CANNULA BENT UNABLE TO CONFIRM IF CUSTOMER RECEIVED SENSOR IN SAID CONDITION, DUE TO CUSTOMER RETURNING IT OPENED AND USED. NO BROKEN OR MISSING ANOMALIES WERE OBSERVED DURING ANALYSIS.

    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

    THE CUSTOMER CALLED IN TO REPORT THAT SHE WAS EXPERIENCING ISSUES WITH HER NEW SENSOR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 141 MG/DL. THE CUSTOMER STATES THAT HER LAST TWO SENSORS WOULD TELL HER THAT HER BLOOD GLUCOSE LEVEL WAS IN THE FORTIES AND SHE WOULD RECEIVE A THRESHOLD SUSPENSE. SHE SAID THAT SHE WOULD CHECK HER BLOOD GLUCOSE LEVEL ON HER METER AND THE LEVEL WOULD READ BETWEEN 95-120 MG/DL. THE CUSTOMER STATES THAT WHEN SHE WOULD CALIBRATE SHE WOULD ALSO RECEIVE A CALIBRATION ERROR AND BE PROMPTED TO REMOVE THE SENSOR AFTER IT HAD ONLY BEEN IN FOR THREE DAYS. THESE OCCURRENCES HAPPENED TWO FULL NIGHTS AND ONCE DURING THE DAY AND SHE ALSO NOTICED A SENSOR WAS BENT. WE ADVISED THE CUSTOMER TO KEEP THE SENSORS WHEN SHE HAS THESE ISSUES SO THAT WE MAY TROUBLESHOOT OVER THE PHONE AND TO NOT DISCARD THEM SO THAT THEY MAY BE SENT BACK FOR ANALYSIS IF NEEDED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411255 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG038BJ

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR