BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16512187 · Received March 9, 2023

    Report

    Report Number
    1823260-2023-00742
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 8, 2023
    Report Date
    April 12, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CODE A (A090806) WAS UPDATED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION IS PATIENT/CONSUMER. THE 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.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR 1 PATIENT TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). ON (B)(6) 2023 THE PATIENT HAD THE BELOW RESULTS: METER RESULT: 3.8 INR AT 3:57 P.M., METER RESULT: 2.4 INR AT 4:04 P.M., METER RESULT: 2.8 INR AT 4:08 P.M. A NEW FINGER WAS USED FOR EACH TEST. THE PATIENT'S THERAPEUTIC RANGE WAS 2.5-3.5 INR AND THE INTERVAL OF TESTING IS ONCE PER WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625939 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 63658921 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male ASCORBIC ACID 500MG| ATORVASTATIN| BABY ASPIRIN| FOLIC ACID| IRON| LOSARTAN| METOPROLOL| MULTIVITAMINS| PANTOPRAZOLE| SERTRALINE| WARFARIN