BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1020695 · Received March 21, 2008

    Report

    Report Number
    2183502-2008-00051
    Event Type
    Injury
    Date Received
    March 21, 2008
    Date of Event
    February 19, 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
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL DELIVERY AND ACCURACY TESTS. THE PUMP HISTORY WAS DOWNLOADED AND ANALYZED NO ANOMALIES WERE FOUND. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPEC.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008 DUE TO AN INCIDENT OF HYPOGLYCEMIA. THE PT REPORTED THAT HE WAS STUCK ON A TRAM WITH NO ACCESS TO FOOD. WHEN HE WAS FINALLY ABLE TO GET OFF THE TRAM HE WAS UNABLE TO LOCATE ANYTHING TO EAT. HE REPORTS THAT HE PASSED OUT DUE TO LOW BLOOD SUGAR. THE PARAMEDICS TREATED HIM WITH GLUCOSE GEL AND TRANSPORTED HIM TO THE HOSP. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE.

    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