BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6904303 · Received September 29, 2017

    Report

    Report Number
    1823260-2017-02156
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    September 13, 2017
    Report Date
    November 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED BY THE CUSTOMER; THEREFORE NO FURTHER INVESTIGATION WAS POSSIBLE. NONE OF THE GIVEN TREATMENTS/MEDICATIONS ARE CURRENTLY KNOWN TO INTERFERE WITH THE ACCURACY OF THE TEST RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT AT 12:47 PM WAS 2.4 INR AND THE RESULT AT 12:51 PM WAS 1.9 INR. THE CUSTOMER STATED SHE SQUEEZED MORE BLOOD OUT OF THE SAME FINGERSTICK FOR THE SECOND TEST. THE CUSTOMER WAS ADVISED TO ALWAYS USE A NEW STICK AND A NEW FINGER FOR EACH TESTING. THE CUSTOMER WAS ANEMIC AND WAS ADVISED OF THE LIMITATIONS. SHE WAS NOT ON HEPARIN, HAD NO ANTIPHOSPHOLIPID ANTIBODIES, AND HAD NO CHANGE IN COUMADIN. THE CUSTOMER HAD NO NEW MEDICATIONS, NO CHANGE IN DIET. SHE HAD A MIGRAINE ON (B)(6) 2017. THE THERAPEUTIC RANGE WAS 3.0-4.0 INR. NO TREATMENT WAS BASED ON THE RESULTS AND THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 223855) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM (B)(6) DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684525 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385523

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR