BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 12507123 · Received September 21, 2021

    Report

    Report Number
    1823260-2021-02751
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    04015630945689
    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

    SECTION D4: CATALOG NUMBER, MODEL NUMBER AND UNIQUE IDENTIFIER (UDI) # WERE UPDATED. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    OCCUPATION IS LAY USER/PATIENT. THE METER WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    WE RECEIVED AN ALLEGATION OF A SOFTWARE ISSUE WITH A COAGUCHEK XS METER. THE METER WAS SET TO %Q UNITS INSTEAD OF INR. THE REPORTER STATED THEIR WARFARIN DOSE WAS INCREASED BASED ON A LOW RESULT OF 1.5 INR. WHEN THE METER MEMORY WAS REVIEWED, THERE WAS NO RESULT OF 1.5 INR. THERE WAS A RESULT OF 15 %Q ON (B)(6) 2021 AT 9:33 P.M. WHEN THE UNITS WERE CHANGED TO INR, THE RESULT FROM THE MEMORY WAS 3.5 INR ON (B)(6) 2021 AT 9:33 P.M. THE REPORTER WAS UNABLE TO CLARIFY IF A RESULT OF 1.5 INR WAS REPORTED BASED ON THE RESULT OF 15 %Q OR IF THE LOW RESULT OF 1.5 INR WAS MISSING FROM THE MEMORY. THE REPORTER ALSO QUESTIONED A HIGH RESULT OF 4.1 INR ON (B)(6) 2021; ONLY ONE TEST WAS PERFORMED ON THIS DAY. WHEN THE METER MEMORY WAS REVIEWED, A RESULT OF 11 %Q WAS DISPLAYED ON (B)(6) 2021 AT 4:28 P.M. WHEN THE UNITS WERE CHANGED TO INR, THE RESULT WAS 4.5 INR; THERE WAS NO RESULT OF 4.1 INR. A DISPLAY CHECK WAS PERFORMED AND THERE WERE NO MISSING SEGMENTS. THE DATE WAS SET CORRECTLY. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403509 COAGUCHEK XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS XS PST NA 04015630945689

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR APPLE CIDER VINEGAR TABLETS| COENZYME Q10| CRANBERRY PILLS| ESCITALOPRAM| K2| LONGEVITY BY SWANSON| SPIRONOLACTONE| SULFAMETHOXAZOLE| SWANSON, TURMERIC AND BLACK PEPPER| TAMSULOSIN HCL| TRAZODONE| VITAMIN D3| WARFARIN| APPLE CIDER VINEGAR TABLETS| COENZYME Q10| CRANBERRY PILLS| ESCITALOPRAM| K2| LONGEVITY BY SWANSON| SPIRONOLACTONE| SULFAMETHOXAZOLE| SWANSON, TURMERIC AND BLACK PEPPER| TAMSULOSIN HCL| TRAZODONE| VITAMIN D3| WARFARIN