BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1171482 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06946
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE SUSPECT DEVICE USED IN SYSTEM #1. PLEASE SEE MEDWATCH FOR SUSPECT DEVICE IN INFORM SYSTEM #2.

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK RESULTS OF 409MG/DL ON INFORM SYSTEM #1 COMPARED TO RESULTS OF 183MG/DL ON INFORM SYSTEM #2. CALLER REPORTS QUALITY CONTROLS PASSED. NO ADVERSE EVENT REPORTED. 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 550757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LEVOFLOXACIN| MAGNESIUM OXIDE| METOPROLOL XL| TAMSULOSIN| ANTACID SUSPENSION| CHOLESTYRAMINE LITE| FINASTERIDE| FUROSEMIDE| BACITRACIN OINTMENT| TRAMADOL| ALFUZOSIN ER| LORTAB| ACETAMINOPHEN