BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3162635 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03528
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS REPORTED AS (B)(6); HOWEVER, NO UNIT OF MEASURE WAS PROVIDED. LOCATION WHERE EVENT OCCURRED WAS REPORTED AS "CUSTOMER" . THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTER STATED THAT A PATIENT CAPILLARY SAMPLE WAS TESTED ON THE COAGUCHEK XS SYSTEM WITH A RESULT OF 3.5 INR. AT THE SAME TIME, A VENOUS SAMPLE, OBTAINED FROM THE SAME PATIENT, REPORTEDLY MEASURED 2.3 INR ON AN UNSPECIFIED LABORATORY INSTRUMENT. NO ACTION BASED ON THE COAGUCHEK XS RESULT WAS REPORTED AND NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262849 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21815314

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR UNSPECIFIED "ARTICULAR-PILL"| BISOHEXAL| FALITHROM| SIMVA-ARISTO| UNSPECIFIED PULSE REDUCTION MEDICATION| RAMIPRIL| ALLOPURINOL