BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3924369 · Received July 9, 2014

    Report

    Report Number
    2032227-2014-03473
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 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 ALSO MFR REPORT NUMBER 3004209178-2014-86505.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD A ROUTINE VISIT WITH HER PHYSICIAN AT THE HOSPITAL AND WHEN THE NURSE CHECKED HER BLOOD GLUCOSE FOUND THAT IT WAS CLOSE TO 500 MG/DL. CUSTOMER STATED THAT SHE WAS WHEELCHAIRED TO THE EMERGENCY ROOM AND HER BLOOD GLUCOSE WAS OVER 600 MG/DL AT THE TIME OF ADMISSION. CUSTOMER ALSO STATED THAT HER SENSORS TAPE WAS GIVING HER ISSUES AND SHE HAS NOT BEEN ABLE TO USE THEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401489 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization