BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMONITOR GLUCOSE MONITOR

    MDR report key: 1151374 · Received September 4, 2008

    Report

    Report Number
    2183502-2008-00255
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 4, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. ACCURACY TESTS WERE PERFORMED WITH CONTROL SOLUTIONS. THE DEVICE WAS FOUND TO BE MEASURING ACCURATELY. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPECIFICATION. NOTE: THE CUSTOMER DID NOT RETURN OR IDENTIFY THE TEST STRIPS THAT THEY HAD USED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT THE PT WAS TREATED BY PARAMEDICS DUE AN INCIDENT OF LOW BLOOD GLUCOSE. THE REPORTER STATED THAT THE INSULIN INFUSION PUMP WITH BLOOD GLUCOSE MONITOR GAVE A RESULT OF 357 MG/DL. REPORTEDLY, THE PT HAD A HYPOGLYCEMIC REACTION. THE PARAMEDICS WERE SUMMONED; THEIR METER GAVE A RESULT OF 32 MG/DL. THE PT WAS TREATED ON SCENE AND NOT TRANSPORTED. THE DEVICE SHOULD BE RETURNED FOR EVAL; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMONITOR GLUCOSE MONITOR GLUCOSE MONITOR NBW SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1790 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DELTEC COZMO INSULIN PUMP 1800 A71209