BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4490527 · Received February 6, 2015

    Report

    Report Number
    2032227-2015-05562
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    January 25, 2015
    Report Date
    January 26, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED PARTIAL ENLITE SENSOR AND PERFORMED THE SENSOR INITIALIZATION TEST. THE SENSOR FUNCTIONED PROPERLY. THE CANNULA WAS BENT, BUT COULD NOT CONFIRM THAT THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITION DUE TO THE PRODUCT BEING RETURNED OPENED/USED. UNABLE TO CONFIRM THE NEEDLE ANOMALY DUE TO THE NEEDLES NOT BEING RETURNED.

    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. MEDTRONIC, INC. (

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE SENSOR. CUSTOMER STATES, HE WAS TRYING TO INSERT THE SENSOR AND THE NEEDLE BENT. CUSTOMER ALSO REPORTED HIS BLOOD GLUCOSE WAS 46 MG/DL BUT DID NOT RECALL THE TIME OF THE ISSUES. TROUBLESHOOTING FOR SENSOR ALARMS WAS PERFORMED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87586 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0CS4A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention