BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1201805 · Received October 15, 2008

    Report

    Report Number
    2183502-2008-00301
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 14, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL DELIVERY AND ACCURACY TESTS. THE PUMP HISTORY WAS DOWNLOADED AND ANALYZED NO ANOMALIES WERE FOUND. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. PER THE PATIENT, SHE WOKE UP ON THE DAY BEFORE, AND TESTED HER BLOOD GLUCOSE AND IT WAS 97 MG/DL. SHE CHANGED HER ADMINISTRATION SET AND SITE. BY 3:00 PM THAT DAY, SHE FELT "HIGH" AND TESTED IN THE HIGH 200'S. BY 5:00 PM, SHE WAS AT 460 MG/DL. SHE THEN WENT TO CLASS, AFTER CLASS AT 9:30 PM, SHE WAS 517 MG/DL. AN HOUR LATER AT HOME, SHE TESTED AT 582 MG/DL. BY THIS TIME, SHE WAS VOMITING AND HAD LARGE KETONES. SHE CALLED HER MEDICAL INSURANCE COMPANY'S ON-CALL NURSE WHO RECOMMENDED SHE GO TO THE ER. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS, ADMITTED AND TREATED WITH IV INSULIN AND FLUIDS. THE DEVICE WILL BE RETURNED FOR EVALUATION; 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 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization