BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 10408565 · Received August 14, 2020

    Report

    Report Number
    1823260-2020-02000
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 14, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(4). THE CUSTOMER'S STRIPS WERE RETURNED FOR INVESTIGATION. THE RETURNED PRODUCT WAS TESTED USING REFERENCE METERS WITH A HIGH LEVEL CONTROL SAMPLE. TWO VIALS OF TEST STRIP BOTH LOT 417472-11 WERE RETURNED (VIAL NUMBERS 380543 AND 381256). TESTING RESULTS (QC RANGE: 2.7-3.3 INR): VIAL NUMBER 380543: QC 1: 3.0 INR, QC 2: 3.0 INR, QC 3: 2.9 INR. VIAL NUMBER 381256: QC 1: 2.9 INR, QC 2: 2.9 INR, QC 3: 3.0 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED TARGET RANGES, CONFIRMING THE FUNCTIONALITY OF THE COMPLAINED COAGUCHEK TEST STRIPS. NO ERROR MESSAGES OCCURRED. PRODUCT LABELING STATES: "THE COAGUCHEK SYSTEM USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS DEVIATIONS CAN OCCUR WHEN COMPARED TO METHODS USING OTHER THROMBOPLASTINS. HOWEVER, THOSE DEVIATIONS BETWEEN THROMBOPLASTINS OF DIFFERENT ORIGIN (E.G., RABBIT BASED) ARE NOT SPECIFIC TO COAGUCHEK PRODUCTS. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED TO OTHER LABORATORY METHODS." ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. OCCUPATION IS LAY USER/PATIENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A LABORATORY RESULT USING AN UNKNOWN METHOD. AT 10:30 AM THE LABORATORY RESULT WAS 2.4 INR. AT 10:51 AM THE METER RESULT WAS 3.6 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.5-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875094 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 41747211

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR