BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942864 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04471
    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
    MO
    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. 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 THAT THE SENSOR GAVE INACCURATE READINGS. SHE STATED THAT WHEN THE BLOOD GLUCOSE READING WAS 189 MG/DL, THE SENSOR GLUCOSE READING WAS 46 MG/DL. CUSTOMER ALSO REPORTED THAT SHE WAS WOKEN UP WITH THE INSULIN PUMP ALARMING FOR THRESHOLD SUSPEND WHEN THE BLOOD GLUCOSE WAS 440 MG/DL, AND THAT THE BLOOD GLUCOSE WENT DOWN TO 60 MG/DL AFTER THAT. CUSTOMER WAS NOT FOLLOWING PROPER PROCEDURE AND DID NOT CALIBRATE WHEN THE BLOOD GLUCOSE WAS STABLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419971 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C264U

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR