BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 785251 · Received July 22, 2006

    Report

    Report Number
    1823260-2006-03814
    Event Type
    Malfunction
    Date Received
    July 22, 2006
    Date of Event
    July 12, 2006
    Report Date
    July 13, 2006
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE, MEASURED 150, 307, AND 201 MG/DL WHEN TESTING WAS PERFORMED WITHIN 1 MIN OF EACH OTHER. IT WAS STATED CUSTOMER TOOK NORMAL 80 UNITS OF INSULIN AS WELL AS ADDED 3 UNITS OF INSULIN DUE TO THE RESULT. CUSTOMER STATED 2 HRS LATER FELT GLUCOSE WAS DROPPING. HOWEVER, ATE SOMETHING AND FELT BETTER. NO OTHER ACTIONS TAKEN AND NO TREATMENT WAS RECIVED REPORTEDLY AS A RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT 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 TEST STRIPS LFR ROCHE DIAGNOSTICS CORP. * 549103

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NEUROTIN| ZOCOR| NOVOLOG| LANTUS| ACCU-CHEK ADVANTAGE METER.| VOICEMATE VSR WITH CHEK VIAL.| PAXIL| GLUCOVANCE| TOPROL XL| RITALIN| ADAVANT| ZETIA