BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1020696 · Received March 21, 2008

    Report

    Report Number
    2183502-2008-00057
    Event Type
    Injury
    Date Received
    March 21, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 20, 2008
    Manufacturer
    SMITHS MEDICAL MD, FORMERLY DELTEC INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURE NARRATIVE: 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

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF HYPOGLYCEMIA. THE REPORTER STATED THAT DURING THE EVENING OF 2008, THE PT'S BLOOD GLUCOSE BEGAN RUNNING LOW. HE HAD A SNACK THEN BLOUSED INSULIN. ONE HOUR LATER HE WAS STILL LOW. HE HAD 2 COOKIES AND SOME JUICE. AT 3:30AM THE NEXT DAY, HE WAS AT 5MMOL/L, HE HAD MORE COOKIES AND JUICE. AT 7:15AM THE PT HAD A BLOOD GLUCOSE OF 4.1MMOL/L HE WAS GIVING GLUCAGON AND TRANSPORTED TO THE HOSPITAL. AT THE HOSPITAL HE WAS OBSERVED AND RELEASED. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE. THE REPORTER AGREED TO SECURE MORE PRODUCT TRAINING FOR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD, FORMERLY DELTEC INC. 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization