BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4862447 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19857
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 VIA PHONE CALL THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND WITH A BLOOD GLUCOSE LEVEL OF 194 MG/DL AND A SENSOR GLUCOSE LEVEL OF 75 MG/DL. THE CUSTOMER ALSO STATED THAT THE DAY PRIOR TO THE CALL, SHE HAD A BLOOD GLUCOSE LEVEL OF 43 MG/DL AND A SENSOR GLUCOSE LEVEL OF 121 MG/DL. THE CUSTOMER WAS ADVISED THAT THE SENSOR WOULD BE REPLACED BUT WILL NOT RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406249 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1