BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1972405 · Received January 28, 2011

    Report

    Report Number
    1823260-2011-00502
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED INFORM SYSTEM CAPILLARY BLOOD RESULT OF 106 MG/DL AT 16:58, LAB RESULT OF VENOUS BLOOD DRAWN AT 17:05 IN EDTA TUBE OF 57 MG/DL WITHIN 10 MINUTES. AT 03:30, USING SAME VENOUS/EDTA SAMPLE, METER RESULT WAS 12 MG/DL, LAB RESULT WAS 13 MG/DL. CALLER REPORTED THE METER/STRIPS PASSED VALID CONTROL TESTS. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551443

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR COZAAR| GLIPIZIDE| NEURONTIN 3XDAY| VICODIN EVERY 6 HOURS