BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8147296 · Received December 10, 2018

    Report

    Report Number
    1823260-2018-04717
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 16, 2018
    Report Date
    May 10, 2019
    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 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. RELEVANT RETENTION TEST STRIPS (LOT 334499) 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.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A LABORATORY USING STAGO NEOPLASTINE REAGENT. OF THE DATA PROVIDED FOR TWO PATIENTS, ONLY THE RESULTS FOR ONE PATIENT WERE DISCREPANT. THE METER RESULT WAS 4.1 INR AND THE LABORATORY RESULT WAS 3.1 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2.0 INR TO 3.0 INR. THE PATIENT WAS ANEMIC, HAD NO HEPARIN, ANTIPHOSPHOLIPID ANTIBODIES, DIRECT THROMBIN INHIBITORS, NEW MEDICATIONS, DIET CHANGES, OR SYMPTOMS OF BLEEDING OR BRUISING. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RETENTION TEST STRIPS (LOT 334499) WERE TESTED IN COMPARISON TO MASTERLOT #28632180 (RECALIBRATED LOT TO RTF/09). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL COMPLIES WITH SPECIFICATION. THE COMPLAINED TEST STRIPS HAVE BEEN CALIBRATED AGAINST THE WHO STANDARD RTF/16 AND THE AFFECTED BY RECALL. CORRESPONDING RETENTION TEST STRIPS (LOT 334499) WERE TESTED IN COMPARISON TO MASTERLOT #28632180 (RECALIBRATED LOT TO RTF/09). THE CORRESPONDING RETENTION MATERIAL COMPLIES WITH THE SPECIFICATION, BASED ON REQUIREMENTS OF THE REGULAR RETENTION TESTING PROCESS OF THE QC DEPARTMENT. THE RETENTION MATERIAL AND COMPARABLE MASTERLOT TEST STRIPS DID NOT SHOW ABNORMALITIES. INVESTIGATIONS HAVE INDICATED RESULTS ARE RELIABLE FROM 0.8 TO 4.5 INR, SINCE THE CALIBRATION DATA COVERS THIS MEASURING RANGE VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988250 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 33449918

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN