BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMONITOR GLUCOSE MONITOR

    MDR report key: 642431 · Received October 21, 2005

    Report

    Report Number
    2183502-2005-00090
    Event Type
    Injury
    Date Received
    October 21, 2005
    Date of Event
    September 17, 2005
    Report Date
    October 19, 2005
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT HAD BEEN SEEN IN THE ER FOR AN INCIDENT OF HYPOGLYCEMIA. THE PT'S FAMILY MEMBER STATED THAT THE PT'S INSULIN INFUSION PUMP WITH BLOOD GLUCOSE MONITOR GAVE A READING OF 66 MG/DL FOR WHICH THEY BEGAN TO CORRECT WITH ORANGE JUICE. DURING THIS THE PT REPORTEDLY HAD A SEIZURE; THE PT WAS BROUGHT TO THE EMERGENCY ROOM BUT WAS NOT ADMITTED. AFTER RETURNING HOME FROM THE ER THE REPORTER CHECKED THE PT'S BLOOD GLUCOSE EVERY 1-2 HOURS THE DEVICE RETURNED THE FOLLOWING RESULTS; 98, 102, 128. SOMEWHAT LATER THE REPORTER STATED THE PT REPORTED FEELING "TINGLY" THEY THEN CHECKED THE BLOOD GLUCOSE WITH A BACK-UP METER WHICH REGISTERED 89 MG/DL THEY THEN CHECKED WITH THE SUSPECT DEVICE WHICH REGISTERED 148 MG/DL. THE REPORTER IS CONCERNED ABOUT THE DIFFERENT RESULTS WITH TWO DIFFERENT METERS AND IS RETURNING THE ALLEGED DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMONITOR GLUCOSE MONITOR GLUCOSE MONITOR NBW SMITHS MEDICAL MD 1790 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other