BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 17098757 · Received June 9, 2023

    Report

    Report Number
    1823260-2023-01919
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 8, 2023
    Report Date
    June 9, 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 METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION AND HAVE NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.  THE PATIENT STATED HE WAS UNABLE TO GET A METER RESULT AND GOT AN ERROR 5 FOUR TIMES IN A ROW. PRODUCT LABELING STATES "ERROR 5: BLOOD APPLICATION ERROR APPLYING BLOOD TO THE TEST STRIP OR BLOOD SAMPLE SIZE WAS TOO SMALL. SOLUTION: TURN THE METER OFF AND REMOVE THE TEST STRIP. RE-READ THE INSTRUCTIONS ABOUT APPLYING BLOOD (STARTING ON PAGE 33). REPEAT THE TEST WITH A NEW TEST STRIP AND A SUFFICIENT AMOUNT OF BLOOD FROM A DIFFERENT FINGER. IF YOU STILL GET THE ERROR MESSAGE, CALL ROCHE CUSTOMER SUPPORT CENTER AT 1-800-428-4674." THE PATIENT HAS A LUPUS ANTICOAGULANT. PRODUCT LABELING STATES "LIMITATIONS OF PROCEDURE INFORMATION FOR YOU AND YOUR PHYSICIAN - THE PRESENCE OF ANTI-PHOSPHOLIPID ANTIBODIES (APAS) SUCH AS LUPUS ANTIBODIES (LA) MAY LEAD TO PROLONGED CLOTTING TIMES, I.E., THEY MAY CAUSE FALSE-HIGH INR VALUES. IF YOU HAVE OR SUSPECT THAT YOU HAVE APAS, DISCONTINUE TESTING UNTIL YOU DISCUSS WITH YOUR PHYSICIAN." ON A REGULAR BASIS, COAGUCHEK STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND THE RESULTS HAVE PASSED THE INTERNAL INSPECTION.  PRODUCT LABELING STATES: "COAGUCHEK METHOD USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO TESTS USING OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS HIGHER DEVIATIONS CAN OCCUR WITH OTHER THROMBOPLASTIN TYPES. HOWEVER, THOSE HIGHER DIFFERENCES BETWEEN THROMBOPLASTINS OF DIFFERENT (RABBIT, BOVINE) ORIGIN ARE NOT AN ISSUE SPECIFIC FOR COAGUCHEK ASSAYS. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED WITH SEVERAL OTHER (RABBIT, BOVINE) LABORATORY METHODS."  SECTION E3 - OCCUPATION: PATIENT/CONSUMER H3 OTHER TEXT : NA.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF A QUESTIONABLE INR RESULT FOR ONE PATIENT TESTED WITH THE COAGUCHEKXS METER WITH AN UNKNOWN SERIAL NUMBER COMPARED TO AN UNKNOWN LABORATORY METHOD. THE METER RESULT WAS "5. SOMETHING" INR. THE LABORATORY RESULT WAS 3.2 INR. THE RESULTS WERE TAKEN WITHIN 30 MINUTES. THE PATIENT'S THERAPEUTIC RANGE IS 2.5-3.5 INR. THE INTERVAL OF TESTING IS EVERY TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551195 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male "HYDROCHLOROQUIN"| METOPROLOL| OTHER MEDICATIONS| STOMACH MEDICATION| WARFARIN 2.5MG DAILY