BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4251613 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52763
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE OVER 600 MG/DL FOR SEVERAL DAYS. CUSTOMER DID NOT GO TO THE HOSPITAL DESPITE PEOPLE TELLING HER TO GO. CUSTOMER DID GO SEE HER DOCTOR SINCE SHE FELT DEHYDRATED ONCE HER BLOOD GLUCOSE WAS LOWERING. SHE ALSO HAD SWINGS BUT DECIDED NOT TO GO TO THE EMERGENCY ROOM. CUSTOMER WENT ON STATED THE CGM WAS GIVING HER ERRATIC READINGS. CUSTOMER WAS NO LONGER USING THE SENSOR ANYMORE. CUSTOMER STATED BECAUSE THEY WERE TO EXPENSIVE AND INSURANCE DOES NOT COVER THEM. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736343 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention UNOMEDICAL INFUSION SET