BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1021213 · Received March 28, 2008

    Report

    Report Number
    1823260-2008-02855
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    HUSBAND REPORTS CUSTOMER TESTED WITH BLOOD GLUCOSE RESULT OF 400MG/DL AND STARTED TO FEEL STRANGE, SHAKY AND HER EYES WERE OPEN, BUT SHE WAS NOT RESPONDING. HUSBAND CALLED EMTS ABOUT HALF HOUR AFTER READINGS AND THEY TESTED CUSTOMER WITH READING OF 31MG/DL AND TOOK HER TO THE HOSPITAL. EMTS TREATED CUSTOMER WITH AN IV OF UNKNOWN CONTENT AND GAVE HER GLUCOSE PASTE. CUSTOMER'S HUSBAND REPORTS THAT ON THE NEXT DAY, A PROFESSIONAL METER RESULT OF 191MG/DL BACK TO BACK COMPARISON TO CUSTOMER'S ADVANTAGE SYSTEM RESULT OF 392MG/DL ON PROFESSIONAL METER. NO QUALITY CONTROL INFORMATION WAS PROVIDED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549915

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention ASPIRIN 81MG/DAY| PLAVIX 75MG/DAY| GLYBURIDE 10MG 2X/DAY| METFORMIN 500MG 2X/DAY| LIPITOR 40MG/DAY