BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 696561 · Received April 3, 2006

    Report

    Report Number
    1823260-2006-01455
    Event Type
    Malfunction
    Date Received
    April 3, 2006
    Date of Event
    March 15, 2006
    Report Date
    March 17, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN RECEIVING ELEVATED BLOOD GLUCOSE RESULTS (181-246 MG/DL, NORMALLY 100-114 MG/DL) ON THE SUSPECT DEVICE. BASED ON ELEVATED RESULTS, PATIENT REPORTEDLY SOUGHT TREATMENT AT THE HOSPITAL. REPORTER STATED THAT PATEINT'S CAPILLARY BLOOD GLUCOSE WAS MEASURED ON A HOSPITAL DEVICE WITH A RESULT OF 70 MG/DL. WITH SECONDS, PATIENT REPORTEDLY RETESTED BLOOD GLUCOSE, USING THE SUSPECT DEVICE, AND OBTAINED A RESULT OF 235 MG/DL. NO PATIENT INJURY WAS REPOTED AND NO TREATMENT WAS RECEIVED. QUALITY CONTROL TESTING HAD NOT BEN PERFORMED ON THE SUSPECT DEVICE. TECHNICAL SUPPORT RREQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA 548535

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN