BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1142741 · Received August 27, 2008

    Report

    Report Number
    2183502-2008-00239
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    May 30, 2008
    Report Date
    August 26, 2008
    Manufacturer
    SMITH MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 AS RECEIVED THAT REPORTED A PATIENT WAS TREATED IN 2008 FOR AN INCIDENT OF DIABETIC KETOACIDOSIS. PER THE REPORT, THE PATIENT HAD BEEN EXPERIENCING LABILE BLOOD GLUCOSE FOR 3 TO 5 DAYS. ADDITIONALLY THEY REPORT SOME CONCERN REGARDING INSULIN RESISTANCE COMPOUNDED BY LONG WORK HOURS AND DIETARY CONCERNS. REPORTEDLY, THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. UPON ADMIT TO THE HOSPITAL, HER BLOOD GLUCOSE WAS 524 MG/DL. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND TREATED WITH IV FLUIDS AND INSULIN. 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 SMITH MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization