BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1032269 · Received April 17, 2008

    Report

    Report Number
    2183502-2008-00097
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 4, 2008
    Report Date
    April 15, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. THE REPORTER STATED THE PATIENT HAD LABILE BLOOD GLUCOSE FOR SEVERAL WEEKS WHICH THEY ATTRIBUTED TO THE PATIENT BEING SICK. THE EVENT DATE, PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED AS IN DKA. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AS OF THE DATE OF THIS REPORT HAD NOT BEEN RETURNED FOR EVALUATION.

    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