BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3852314 · Received June 5, 2014

    Report

    Report Number
    2032227-2014-02900
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER WAS UNABLE TO CORRECTLY CALIBRATE HER INSULIN PUMP AND KEPT RECEIVING CALIBRATION ERRORS AND TWO FAILED DELIVERY ALARMS. CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE DID NOT KNOW EXACTLY WHAT HER BLOOD GLUCOSE LEVEL WAS BUT BELIEVED IT TO BE AROUND 40 MG/DL. BECAUSE OF HER LOW BLOOD GLUCOSE LEVEL, THE CUSTOMER STATED THAT SHE STARTED HAVING CONVULSIONS. HER HUSBAND CALLED THE PARAMEDICS. THE CUSTOMER DETERMINED THAT HER LOW BLOOD GLUCOSE LEVEL RESULTED FROM HER MONTHLY CYCLE AND DAILY ACTIVITIES. SHE DECLINED TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328886 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention