BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1140228 · Received August 29, 2008

    Report

    Report Number
    2183502-2008-00249
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED IN 2008, FOR AN INCIDENT OF DIABETIC KETOACIDOSIS. PER THE REPORTER THE PATIENT'S BLOOD GLUCOSE METER BEGAN READING "HIGH" AND THE PATIENT HAD LARGE KETONES DURING THE AFTERNOON IN 2001. SHE CONTINUED TO HYPERGLYCEMIC THOUGH THE EVENING AND NEXT DAY. AT 2:30 PM IN 2002, SHE WAS BROUGHT TO THE HOSPITAL WHERE UPON ADMIT HER BLOOD GLUCOSE WAS 686 MG/DL. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. SHE 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 AS OF THE DATE OF THIS REPORT HAD NOT BEEN RETURNED FOR EVALUATION.

    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