BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1033296 · Received April 22, 2008

    Report

    Report Number
    2183502-2008-00100
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 22, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TEST 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

    INFO WAS RECEIVED THAT REPORTED A PT WAS TREATED AT HER PHYSICIAN'S OFFICE IN 2008 DUE TO AN INCIDENT OF HYPOGLYCEMIA. THE REPORTER STATES HER DAUGHTER TOOK HER TO HER DOCTOR WHEN HER BLOOD GLUCOSE WAS 27 MG/DL, AND SHE HAD AN ALTERED LEVEL OF CONSCIOUSNESS. 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 DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization