BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 11021377 · Received December 16, 2020

    Report

    Report Number
    1823260-2020-03252
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    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 · 1

    OCCUPATION IS LAY USER/PATIENT. THE CUSTOMER¿S PRODUCT WAS REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, OR FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER MISINTERPRETED %Q RESULTS AS INR RESULT FROM COAGUCHEK METER SERIAL NUMBER (B)(4). THE FOLLOWING RESULTS WERE OBTAINED: ON (B)(6) 2020 THE RESULT WAS 15% Q (3.3 INR); THE CUSTOMER REPORTED THIS RESULT AS 1.5 INR AND THEIR WARFARIN DOSE WAS INCREASED. ON (B)(6) 2020 THE RESULT WAS 14% Q (3.5 INR); THE CUSTOMER REPORTED THIS RESULT AS 1.4 INR. ON (B)(6) 2020 THE RESULT WAS 11% Q (4.4 INR); THE CUSTOMER REPORTED THIS RESULT AS 1.1 INR. ON (B)(6) 2020 THE RESULT WAS 5% Q (8.0 INR); THE CUSTOMER DID NOT REPORT THIS RESULT. ON (B)(6) 2020 THE RESULT WAS 5% Q AND FLAGGED WITH A "C" (8.0 INR); THE CUSTOMER DID NOT REPORT THIS RESULT. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0- 3.0 INR. THE METER DID NOT MALFUNCTION. THE METER CAN DISPLAY RESULTS IN EITHER %Q OR INR. THE CUSTOMER INTERPRETED THE %Q RESULTS FROM THE METER WITH AN IMAGINED DECIMAL POINT IN AN ATTEMPT TO INTERPRET THE NUMBER AS AN INR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488607 COAGUCHEK XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1