BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 694337 · Received March 29, 2006

    Report

    Report Number
    1823260-2006-01407
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Date of Event
    March 17, 2006
    Report Date
    March 17, 2006
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED CUSTOMER PASSED OUT AND TWO DAYS LATER BLOOD GLUCOSE WAS 393 MG/DL. IT WAS REPORTED CUSTOMER WENT TO THE DOCTOR WHERE THEIR DEVICE READ 27 MG/DL HOWEVER CUSTOMER'S METER READ 365/211/409/403 DURING BACK TO BACK TESTING VERSUS THE DOCTOR. TREATMENT INFO WAS NOT PROVIDED. A REQUEST WAS MADE FOR THE RETURN OF THE SUEPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING SYSTEM CFR ROCHE DIAGNOSTICS CORP. NA 548335

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN