BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7270444 · Received February 14, 2018

    Report

    Report Number
    1823260-2018-00439
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 9, 2018
    Report Date
    March 1, 2018
    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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S METER WAS RETURNED FOR INVESTIGATION. THE RETURNED METER WAS MEASURED WITH MASTER LOT STRIPS IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. (B)(6). ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THE PATIENT SAMPLES WERE ALWAYS IDENTIFIED AS BLOOD. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND COMPLAINED OF ERRONEOUS INR RESULTS WHEN THE CUSTOMER TESTED ON COAGUCHEK XS METER SERIAL NUMBER (B)(4) AND COMPARED TO THE LABORATORY USING THE DADE INNOVIN METHOD. THE CUSTOMER TESTED ON THE METER AT 10:00 A.M. AND GOT A RESULT OF 1.7 INR. BLOOD WAS DRAWN FOR THE LABORATORY TEST AND THE RESULT FROM THE LABORATORY AT 10:30 A.M. WAS 2.6 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR. THE CUSTOMER DIDN'T KNOW WHICH RESULTS WERE CORRECT. THE CUSTOMER REPORTED THE RESULT FROM THE METER TO HER DOCTOR BUT DOESN'T REMEMBER IF ANY MEDICATION ADJUSTMENTS WERE MADE. NO ADVERSE EVENT OCCURRED. THE CUSTOMER DID NOT REQUIRE ANY MEDICAL TREATMENT AND CURRENTLY FEELS OK. THE METER HAS NOT BEEN CLEANED RECENTLY AND IT LOOKED DIRTY UNDER THE BLUE LID OF THE DEVICE. THE CUSTOMER HAS SINCE CLEANED UNDER THE LID. THE CUSTOMER HAS BEEN DROPPING BLOOD ON THE TEST STRIP NOT HOLDING THE DROP OF BLOOD TO THE TEST STRIP UNTIL IT BEEPS. THE CUSTOMER IS NOT ANEMIC OR POLYCYTHEMIC. THE CUSTOMER IS NOT ON HEPARIN, LOVENOX OR OTHER DIRECT THROMBIN INHIBITORS. THE CUSTOMER DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER HAS NOT HAD ANY CHANGES IN MEDICATIONS AND HAS NOT BEEN ILL RECENTLY. THE CUSTOMER DID HAVE SOME CABBAGE. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) 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 MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112882 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR OTHER MEDICATIONS - NOT PROVIDED| WARFARIN