BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTCO COZMO INSULIN PUMP

    MDR report key: 1772169 · Received July 23, 2010

    Report

    Report Number
    2183502-2010-00317
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). 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 DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED ON (B) (6)2010, DUE TO AN INCIDENT OF HYPERGLYCEMIA. PER THE REPORTER, THE PATIENT HAD BEEN EXPERIENCING LABILE BLOOD GLUCOSE FOR SEVERAL DAYS WITH UNEXPLAINED HIGHS. ON (B) (6)2010, HIS BLOOD GLUCOSE WAS >500 MG/DL AND HE WAS DEHYDRATED. HE WAS BROUGHT TO THE HOSPITAL. HE WAS ADMITTED AND TREATED WITH INSULIN AND IV FLUIDS. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AT THE TIME OF THIS REPORT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTCO COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization