BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1861929 · Received October 4, 2010

    Report

    Report Number
    2183502-2010-00426
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    August 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL DELIVERY AND ACCURACY TESTS. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPEC.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED ON (B)(6)2010, DUE AN INCIDENT OF DIABETIC KETOACIDOSIS. PER THE PT, SHE HAD BEEN EXPERIENCING LABILE BLOOD GLUCOSE FOR SEVERAL WEEKS WITH FREQUENT UNEXPLAINED HIGHS. ON (B)(6)2010, SHE AWOKE WITH A BLOOD GLUCOSE OF 380 MG/DL. SEVERAL HOURS LATER, HER METER REGISTERED AS "HI". SHE WAS BROUGHT TO THE HOSPITAL. SHE WAS ADMITTED WITH BLOOD GLUCOSE OF 980 MG/DL. SHE WAS DIAGNOSED AS IN DIABETIC KETOACIDOSIS AND TREATED WITH INSULIN AND IV FLUIDS. THE DEVICE SHOULD BE RETURNED FOR EVAL; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AT THE TIME OF THIS REPORT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization