BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1022857 · Received March 31, 2008

    Report

    Report Number
    2183502-2008-00065
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 27, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELEC, INC.)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 HYPERGLYCEMIA. THE REPORTER STATED SHE BECAME ILL WITH VOMITING ONE DAY PRIOR. THE NEXT DAY, SHE BECAME MORE ILL AND WENT TO THE ER. SHE WAS ADMITTED TO THE HOSPITAL AND WAS "HEAVILY MEDICATED" WITH DARVACET AND ADDITIONALLY HAD AN MRI AND A CAT SCAN. ADDITIONALLY, SHE WAS TREATED FOR HIGH BLOOD GLUCOSE. 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 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELEC, INC.) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization