BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16053813 · Received December 27, 2022

    Report

    Report Number
    1823260-2022-04194
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 7, 2022
    Report Date
    February 22, 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

    IMDRF CODES WERE UPDATED. THE PATIENT'S PRODUCT WAS NOT RECEIVED FOR INVESTIGATION AND IT IS NOT EXPECTED TO BE RETURNED. THE PROBLEMS THAT THE PATIENT HAD WITH HER METER WERE ALREADY SOLVED BY THE TECHNICAL SERVICE TROUBLE SHOOTING. ALL STRIP LOTS INCLUDE THE UPDATED LABELING AND STATES: CAUTION: THE COAGUCHEK XS METER IS PRE-SET TO DISPLAY RESULTS IN THE INTERNATIONAL NORMALIZED RATIO (INR). THE METER IS ALSO CAPABLE OF DISPLAYING RESULTS IN SECONDS (DISPLAYED ON METER AS SEC) AND % QUICK (DISPLAYED ON METER AS %Q) (A MEASURING UNIT USED MAINLY BY HEALTHCARE PROFESSIONALS IN EUROPE). WHEN TESTING FOR INR, YOU MUST CONFIRM THAT THE MEASURED RESULT IS DISPLAYED IN INR PRIOR TO USING THE RESULT AND WHENEVER THE DATE AND TIME SETTINGS ARE MODIFIED. TO RESET THE MEASURING UNIT TO INR, FOLLOW THE INSTRUCTIONS IN THE TESTING A BLOOD SAMPLE SECTION OF THE COAGUCHEK XS SYSTEM USER MANUAL FOR SELF-TESTING, VERSION 8.0 AND HIGHER OR CALL THE ROCHE DIAGNOSTICS TECHNICAL SERVICE CENTER AT 1-800-428-4674 FOR ASSISTANCE, IF THE RESULT IS DISPLAYED IN %Q OR SEC.

    Additional Manufacturer Narrative · 0

    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) 2022 AT 1:00 P.M. THE PATIENT HAD AN INITIAL METER RESULT OF 4.1 INR WHILE UPON RE-TEST AT 3:30 P.M. THE METER RESULT WAS 5.4 INR. AND ON (B)(6) 2022 AT AROUND 3:30 P.M. THE PATIENT RE-TESTED RIGHT AWAY USING A DIFFERENT FINGER AND SHE GOT A METER RESULT OF 5.2 INR. THE PATIENT'S THERAPEUTIC RANGE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050355 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 Female