BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 9637327 · Received January 28, 2020

    Report

    Report Number
    1823260-2020-00210
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 28, 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)(6). OCCUPATION: LAY USER/PATIENT. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. RELEVANT RETENTION TEST STRIPS (LOT 414474) 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. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. PER PRODUCT LABELING, "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 COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4), COMPARED TO AN UNKNOWN LABORATORY METHOD. THE RESULT FROM THE METER AT 6:30 A.M. WAS 19 %Q OR 2.7 INR. THE RESULT FROM THE LABORATORY AT 9:00 A.M. WAS 28 %Q OR 2.6 INR. WHEN COMPARING THE INR RESULTS WITH THE %Q RESULTS, THE RESULTS DO NOT MATCH. THE INITIAL REPORTER HAS NOT BEEN ABLE TO PROVIDE ANY MORE INFORMATION ABOUT THESE RESULTS. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 2.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103122 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 41747411

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR