BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENLITE

    MDR report key: 4141871 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33625
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    July 20, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD BEEN HOSPITALIZED FOR AN AUTOMOBILE ACCIDENT DUE TO LOW BLOOD GLUCOSE LEVELS ON (B)(6) OF 2014. BLOOD GLUCOSE LEVEL WAS 22 MG/DL AT TIME OF HOSPITALIZATION. CUSTOMER STATED THEY HAD OVERCORRECTED BASAL AMOUNTS AFTER THEIR DEVICE ALARMED NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 143 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621725 ENLITE OZO OZO MEDTRONIC MINIMED 7005739-002

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization