BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16753841 · Received April 17, 2023

    Report

    Report Number
    1823260-2023-01283
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 17, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702128101
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S TEST 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. 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.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS FOR FOUR PATIENTS WITH COAGUCHEK XS METER (SERIAL NUMBER UNKNOWN) COMPARED TO THE STAGO SATELLITE METHOD. PATIENT 1: BETWEEN 7:30 A.M. AND 9:30 A.M. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 2.6 INR. WITHIN 4 HOURS, A SAMPLE FROM THE PATIENT WAS TESTED USING THE STAGO SATELLITE METHOD, RESULTING IN A VALUE OF 2.0 INR. THE PATIENT'S DOSE ADJUSTMENT WAS BASED ON THE METER. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR. PATIENT 2: AT AN UNKNOWN POINT IN TIME ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 4.0 INR. AT AN UNKNOWN POINT IN TIME ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE STAGO SATELLITE METHOD, RESULTING IN A VALUE OF 2.5 INR. PATIENT 3: AT AN UNKNOWN POINT IN TIME ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 2.8 INR. AT AN UNKNOWN POINT IN TIME ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE STAGO SATELLITE METHOD, RESULTING IN A VALUE OF 2.1 INR. PATIENT 4: AT AN UNKNOWN POINT IN TIME ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 4.0 INR. AT AN UNKNOWN POINT IN TIME ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE STAGO SATELLITE METHOD, RESULTING IN A VALUE OF 3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309334 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 62215312 00365702128101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown