BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1142749 · Received August 27, 2008

    Report

    Report Number
    2183502-2008-00241
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 26, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    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 TREATED IN 2008 FOR AN INCIDENT OF HYPERGLYCEMIA. PER THE REPORTER FOR A DAY PRIOR TO THE HOSPITALIZATION, SHE WAS SICK WITH VOMITING, WHEN SHE WOULD CHECK HER BLOOD GLUCOSE HER METER READ "HI", SHE REPORTS BEING UNSURE OF HOW TO INTERRUPT THIS INFORMATION. SHE WENT TO BED THAT EVENING AND WAKING UP THE NEXT DAY FEELING WORSE. SHE WAS BROUGHT TO THE HOSPITAL WHERE UPON ADMIT, HER BLOOD GLUCOSE WAS 1100 MG/DL. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND 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 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization