BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4153437 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35157
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED ONE OPENED/USED SENSOR, PERFORMED VISUAL INSPECTION AND FOUND BENT CANNULA. UNABLE TO CONFIRM SENSOR ANOMALY, DUE TO SENSOR BEING OPENED/USED.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE MEDWATCH REPORT # 2032227-2014-35151.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR READING WAS BELOW 60 MG/DL, WHILE HER BLOOD GLUCOSE WAS 107 MG/DL. THE LOW THRESHOLD ON HER INSULIN PUMP WAS SET TO 60 MG/DL AND THE LOW SENSOR READINGS WERE CONSISTENTLY TRIGGERING PROMPTS TO SUSPEND INSULIN DELIVERY. UPON REMOVAL, IT WAS FOUND THAT THE SENSOR WAS A LITTLE BIT CURVED BUT NOT DAMAGED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630362 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG06VKL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR