BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 14876894 · Received June 30, 2022

    Report

    Report Number
    1823260-2022-01928
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 30, 2022
    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 CUSTOMER WAS ASSISTED WITH CHANGING THE UNIT OF MEASURE ON THE METER FROM %Q TO INR. THE REPORTER'S STRIPS WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED USING A RETENTION METER AND CONTROLS. TESTING RESULTS (QC RANGE = 2.1 - 3.3 INR): QC 1: 3.0 INR, QC 2: 3.0 INR, QC 3: 3.0 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. 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." OCCUPATION WAS PATIENT/CONSUMER.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 10:30 AM, THE RESULT FROM THE LABORATORY USING AN UNKNOWN REAGENT WAS 2.6 INR. AT 1:42 PM, THE RESULT FROM THE METER WAS 15%Q (3.4 INR). THE CUSTOMER IS ON A LOW SODIUM DIET. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR AND THE CUSTOMER TESTS EVERY TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397462 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 57790221 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female ASPIRIN,| CALCIUM,| CARDIA,| IRON,| OMEPRAZOLE,| PROBIOTIC,| SERTRALINE,| SPIRONOLACTONE,| SYNTHROID,| TORSEMIDE.| TRELEG,| WARFARIN,