BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4173718 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38359
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE GLUCOSE SENSORS WERE RECEIVED WITH BENT CANULA. UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED THE GLUCOSE SENSORS IN SAID CONDITION DUE TO THE CUSTOMER RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BENT SENSOR. CUSTOMER ALSO REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. BLOOD GLUCOSE AT THE TIME OF 911 CALL WAS 500 MG/DL. CUSTOMER STATED THAT THE CANNULA WAS BENT ON INFUSION SET. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF 911 CALL. CUSTOMER STATED THAT HE DID NOT GET NO DELIVERY ALARMS AS HE WAS LOOKING FOR THEM SINCE HIS BLOOD GLUCOSE LEVELS WAS GOING UP. ADVISED CUSTOMER THAT HE MAY HAVE HAD A PARTIAL OCCLUSION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655293 SENSOR ENLITE OZO OZO MMT-7008A G174U

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR