BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4250936 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52531
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.THIS IS 2 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. PLEASE SEE MEDWATCH REPORT # 2032227-2014-52582.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR GAVE A READING OF 58 MG/DL WHEN HER BLOOD GLUCOSE WAS 110 MG/DL, CAUSING HER INSULIN PUMP TO ALARM WITH THE OPTION TO SUSPEND INSULIN DELIVERY FOR SEVERAL HOURS WHILE SHE WAS TRYING TO SLEEP. THE CUSTOMER DECLINED SENSOR TROUBLESHOOTING. NOTHING FRUTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738009 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR UNOMEDICAL INSULIN INFUSION SET