BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8663235 · Received June 3, 2019

    Report

    Report Number
    1823260-2019-02040
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 15, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    OCCUPATION: OCCUPATION IS LAY USER/PATIENT. THIS EVENT OCCURRED IN (B)(6). RELEVANT RETENTION TEST STRIPS (LOT 345213) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. 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. 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.

    Description of Event or Problem · 1

    THE INITIAL REPORTER QUESTIONED 3 INR COMPARISON RESULTS BETWEEN THE COAGUCHEK INRANGE METER WITH SERIAL NUMBER (B)(4) COMPARED TO THE STAGO NEOPLASTIN CI+ LABORATORY METHOD. OF THE DATA PROVIDED, THE RESULTS FROM 1 COMPARISON WERE DISCREPANT. THE RESULT FROM THE METER WAS 3.70 INR. THE RESULT FROM THE LABORATORY WITHIN 3 HOURS WAS 2.80 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2 - 3 INR. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456170 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 34521313

    Patients

    Seq Age Sex Outcome Treatment
    1