BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1780876 · Received July 30, 2010

    Report

    Report Number
    2183502-2010-00338
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED ON (B)(6) 2010, DUE AN INCIDENT OF DIABETIC KETOACIDOSIS. PER THE REPORTER THE PT WAS BROUGHT TO THE HOSPITAL WHEN HER BLOOD GLUCOSE WAS "300 TO 400" MG/DL. SHE WAS ADMITTED AND TREATED WITH INSULIN AND IV FLUIDS. THE DEVICE SHOULD BE RETURNED FOR EVAL; 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 23 YR Hospitalization