BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 17385853 · Received July 24, 2023

    Report

    Report Number
    1823260-2023-02458
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 24, 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

    E3-OCCUPATION IS PATIENT/CONSUMER 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. PRODUCT LABELING STATES: "THE COAGUCHEK SYSTEM USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS DEVIATIONS CAN OCCUR WHEN COMPARED TO METHODS USING OTHER THROMBOPLASTINS. HOWEVER, THOSE DEVIATIONS BETWEEN THROMBOPLASTINS OF DIFFERENT ORIGIN (E.G., RABBIT BASED) ARE NOT SPECIFIC TO COAGUCHEK PRODUCTS. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN BASED LABORATORY METHOD IS COMPARED TO OTHER LABORATORY METHODS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. N.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6) COMPARED TO A LABORATORY USING AN UNKNOWN REAGENT. AT 5:15 PM, THE METER RESULT WAS 4.4 INR. THE PATIENT WAS NOT FEELING WELL SO THEY WENT TO THE ER FOR A LAB TEST. AT 6:45 PM TO 7:00 PM, THE RESULT FROM THE LABORATORY WAS 2.65 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE PATIENT'S TESTING FREQUENCY VARIES BETWEEN WEEKLY TO MONTHLY BASED ON IF THEY ARE IN THEIR NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632424 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 65031621 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male AMOXICILLIN| ATORVASTATIN| BIKTARVY| CARVEDILOL| DOXYCYCLINE| DULOXETINE| OTEZLA| PANTOPRAZOLE| TYLENOL 3| WARFARIN