BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1760394 · Received July 12, 2010

    Report

    Report Number
    2183502-2010-00284
    Event Type
    Injury
    Date Received
    July 12, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 9, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K031738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED ON (B) (6)2010, DUE TO AN INCIDENT OF HYPERGLYCEMIA. PER THE PATIENT, HIS BLOOD GLUCOSE ON (B) (6) AT 9:30 PM WAS 142 MG/DL. THE NEXT DAY THE PATIENT AWOKE AT 11 AM AND HIS BLOOD GLUCOSE WAS "HIGH" AND HE WAS ILL. SIX HOURS LATER HE WAS BROUGHT TO THE HOSPITAL. UPON ADMIT, HIS BLOOD GLUCOSE WAS 379 MG/DL AND HE WAS TREATED WITH IV FLUIDS AND INSULIN. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; 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 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization