BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4230581 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-37088
    Event Type
    Malfunction
    Date Received
    October 11, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    THE CUSTOMER REPORTED THAT WHEN SHE WAS TRYING TO INSERT A NEW SENSOR THE SERTER DEVICE DID NOT FIRE. CUSTOMER'S BLOOD GLUCOSE WAS 37 MG/DL. CUSTOMER TREATED WITH A POWER BAR. TROUBLESHOOTING WAS DONE. ASSISTANCE PROVIDED TO CUSTOMER, GOT THE NEXT SENSOR TO INSERT SUCCESSFULLY. ADVISED THE CUSTOMER THAT THE SENSOR WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645702 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A HG0801F

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR