BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 2081355 · Received April 28, 2011

    Report

    Report Number
    2183502-2011-00383
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED ON (B)(6) 2011 DUE AN INCIDENT OF HYPERGLYCEMIA. PER THE REPORT THE PATIENT BEGAN EXPERIENCING FLU-LIKE SYMPTOMS ON (B)(6) 2011 WITH VOMITING. ON THE MORNING OF (B)(6) 2011 HIS BLOOD GLUCOSE WAS >500 MG/DL. HE WAS BROUGHT TO THE HOSPITAL THE EVENING OF (B)(6) 2011 DUE TO HYPERGLYCEMIA. UPON ADMIT HIS BLOOD GLUCOSE WAS 835 MG/DL. 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 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization