BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4173271 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29938
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 540 MG/DL, TREATED BY MANUAL INJECTION. CUSTOMER'S MOM SHE HAD TO SHUT OFF THE INSULIN PUMP BECAUSE IT KEPT ALARMING EVERY FIVE MINUTES SENSOR ERROR. CUSTOMER'S MOTHER STATED THE CUSTOMER IS TRAUMATIZED BY THE SENSOR. CUSTOMER HAS FAINTED DUE TO INSERTION ISSUES. CUSTOMER'S MOTHER STATED THAT SHE HAD TO PUT COLD COMPRESSES ON THE CUSTOMER'S NECK TO KEEP HER FROM PASSING OUT. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603679 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR