BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1151375 · Received September 4, 2008

    Report

    Report Number
    2183502-2008-00253
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 3, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. OCCLUSION, DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL OCCLUSION, 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 REC'D THAT REPORTED A PT WAS HOSPITALIZED IN '08 DUE TO AN AN INCIDENT OF HYPERGLYCEMIA. THE REPORTER STATED THE PT WOKE UP ILL, VOMITING AND WEAK ON THAT DAY. A LITTLE LATER, HE PASSED OUT AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS WERE THE FIRST TO TEST HIS BLOOD GLUCOSE AND IT WAS 485 MG/DL. THEY ROUSED THE PT AND TRANSPORTED HIM. UPON ADMIT, THE PT WAS DIAGNOSED WITH DKA AND TREATED WITH INSULIN AND IV FLUIDS. THE INSULIN PUMP 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