BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16537136 · Received March 14, 2023

    Report

    Report Number
    1823260-2023-00797
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 14, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. ON A REGULAR BASIS, COAGUCHEK STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION. FOR THE SEC UNIT OF MEASURE, ALL STRIP LOTS INCLUDE THE UPDATED LABELING AND STATES: "CAUTION: THE COAGUCHEK XS METER IS PRE-SET TO DISPLAY RESULTS IN THE INTERNATIONAL NORMALIZED RATIO (INR). THE METER IS ALSO CAPABLE OF DISPLAYING RESULTS IN SECONDS (DISPLAYED ON METER AS SEC) AND % QUICK (DISPLAYED ON METER AS %Q) (A MEASURING UNIT USED MAINLY BY HEALTHCARE PROFESSIONALS IN EUROPE). WHEN TESTING FOR INR, YOU MUST CONFIRM THAT THE MEASURED RESULT IS DISPLAYED IN INR PRIOR TO USING THE RESULT AND WHENEVER THE DATE AND TIME SETTINGS ARE MODIFIED. TO RESET THE MEASURING UNIT TO INR, FOLLOW THE INSTRUCTIONS IN THE TESTING A BLOOD SAMPLE SECTION OF THE COAGUCHEK XS SYSTEM USER MANUAL FOR SELF-TESTING, VERSION 8.0 AND HIGHER OR CALL THE ROCHE DIAGNOSTICS TECHNICAL SERVICE CENTER AT 1-800-428-4674 FOR ASSISTANCE, IF THE RESULT IS DISPLAYED IN %Q OR SEC." PER PRODUCT LABELING: COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS HIGHER DEVIATIONS CAN OCCUR WITH OTHER THROMBOPLASTINS. HOWEVER, THOSE HIGHER DIFFERENCES BETWEEN THROMBOPLASTINS OF DIFFERENT (RABBIT, BOVINE BASED) ORIGIN ARE NOT A COAGUCHEK SPECIFIC ISSUE. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED AGAINST SEVERAL OTHER (RABBIT, BOVINE-BASED) LABORATORY METHODS. PATIENT/CONSUMER. NA.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS FOR 1 PATIENT TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. THE PATIENT HAD A METER RESULT OF 6.0 INR THEN THE PATIENT WENT TO THE DOCTOR'S OFFICE WHERE HE TESTED ON THE DOCTOR'S NON-ROCHE PROFESSIONAL METER AND GOT A RESULT OF 3.0 INR. HE THEN DID A LABORATORY TEST AND THE RESULT WAS 2.7 INR. THE PATIENT WAS NOT SURE IF THE RESULT OF 6.0 WAS SET TO SEC UNIT OF MEASURE OR INR UNIT OF MEASURE. THE PATIENT REPORTED IT AS 6.0 INR. THE PATIENT'S THERAPEUTIC RANGE WAS 2.5-3.5 INR AND THE INTERVAL OF TESTING IS WEEKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036896 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 62682421 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male PLAVIX (CLOPIDOGREL).| WARFARIN.