BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6839470 · Received September 1, 2017

    Report

    Report Number
    1823260-2017-01884
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 28, 2017
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    ONE VIAL OF TEST STRIP LOT 223855-11 CONTAINING 10 TEST STRIPS AND THE COAGUCHEK XS METER WERE RECEIVED FOR INVESTIGATION. THE TEST STRIPS AND VIAL SHOWED NO DEFECTS. THE METER APPEARED UNDAMAGED AND WAS CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. MASTER LOT /RETENTION METER: MARCUMAR 3: 3.9 INR, MARCUMAR 4: 5.3 INR. CUSTOMER STRIPS/CUSTOMER METER: MARCUMAR 3: 3.9 INR, MARCUMAR 4: 5.4 INR. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH THE SPECIFICATIONS. THE SUSPECT LOT AND METER FULFILLED THE RELEASE CRITERION OF PRODUCT CONTROL. SOME OF THE RESULTS VERBALLY PROVIDED BY THE CUSTOMER WERE NOT PRESENT IN THE MEMORY OF THE RETURNED METER.

    Description of Event or Problem · 1

    A CUSTOMER AND HIS WIFE BOTH HAVE USED THE SAME COAGUCHEK XS METER FOR MORE THAN 10 YEARS. THEIR METER WAS BROKEN AFTER BEING DROPPED AND THE CUSTOMER RECEIVED A NEW COAGUCHEK XS METER SERIAL (B)(4). WITH THE NEW METER, THE CUSTOMER RECEIVED QUESTIONABLE RESULTS WHEN COMPARED TO A LABORATORY USING NEOPLASTIN CI PLUS STAGO ON STA COMPACT AUTOMATON. THE TIME BETWEEN THE METER TESTING AND LABORATORY TESTING WAS 30 MINUTES. THE CUSTOMER'S RESULT AT THE LABORATORY WAS 2 INR AND WITH THE COAGUCHEK XS THE RESULT WAS 2.9 INR. THE CUSTOMER'S WIFE'S RESULT AT THE LABORATORY WAS 1.5 INR AND WITH THE COAGUCHEK XS THE RESULT WAS 3.3 INR. THE CUSTOMER WAS SENT A NEW COAGUCHEK XS METER FOR COMPARISON TESTING. HE TESTED THE TWO METERS WITH THREE DIFFERENT BOTTLES OF STRIPS. ALL COMPARISON RESULTS FOR THE CUSTOMER WERE ACCEPTABLE. FOR THE CUSTOMER'S WIFE, THE RESULTS FROM THEIR METER WERE 2.7 INR, 3.0 INR, AND 3.2 INR. WITH THE COAGUCHEK XS THAT WAS SENT TO THEM, THE RESULTS WERE 1.9 INR, 1.9 INR, AND 1.9 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. HER THERAPEUTIC RANGE WAS 2-2.5 INR. RELEVANT RETENTION TEST STRIPS (LOT 223855-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619831 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385511

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR