BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8015283 · Received October 29, 2018

    Report

    Report Number
    1823260-2018-03892
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    July 5, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    1823260-08/30/18-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. 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. TO MINIMIZE THESE DIFFERENCES, IN A MONITORING SITUATION, IT IS RECOMMENDED THAT EACH SITE USES RESULTS FROM ONE TYPE OF THROMBOPLASTIN METHOD FOR EACH PATIENT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A PATIENT RECEIVED ERRONEOUS RESULTS WHEN TESTING WITH THE PATIENT'S COAGUCHEK INRANGE METER SERIAL NUMBER (B)(4). THE TIME FRAME BETWEEN ALL MEASUREMENTS IS UNKNOWN. THIS MEDWATCH WILL APPLY TO TEST STRIP LOT NUMBER 244033. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO TEST STRIP LOT NUMBER 29778816. A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER USING TEST STRIP LOT NUMBER 29778816, RESULTING WITH A VALUE OF 4.5 INR. AT AN UNKNOWN TIME, A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING AS 3.55 INR. AT A LATER UNKNOWN TIME, A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER USING TEST STRIP LOT NUMBER 29778816, RESULTING WITH A VALUE OF 7.9 INR. AT AN UNKNOWN TIME, A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING AS 4.6 INR. AT A LATER UNKNOWN TIME, A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER USING TEST STRIP LOT NUMBER 29778816, RESULTING WITH A VALUE OF > 8 INR. AT AN UNKNOWN TIME, A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER USING TEST STRIP LOT NUMBER 244033, RESULTING AS 6.6 INR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 297788) WERE TESTED IN COMPARISON WITH THE MASTER LOT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED. EXTENSIVE MEASUREMENTS HAVE SHOWN HIGHER DEVIATIONS FOR COAGUCHEK VALUES > 4.5 INR COMPARED TO A LABORATORY METHOD. THEREFORE, THE CUSTOMER ALLEGATION HAS BEEN SUBSTANTIATED. A PRODUCT PROBLEM HAS BEEN FOUND FOR COAGUCHEK VALUES > 4.5 INR, WHICH WAS THE CASE IN THIS COMPLAINT. THIS CAN BE TRACED BACK TO THE CALIBRATION OF THE COMPLAINED TEST STRIPS TO THE WHO STANDARD RTF/16. FOR MEASUREMENTS > 4.5 INR. THE CUSTOMER IS ADVISED TO CONTACT THE PHYSICIAN AND PERFORM A MEASUREMENT WITH A LABORATORY METHOD. ROCHE DIAGNOSTICS HAS ISSUED A RECALL FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853359 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS NA 244033

    Patients

    Seq Age Sex Outcome Treatment
    1