BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7132964 · Received December 20, 2017

    Report

    Report Number
    1823260-2017-03047
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 7, 2017
    Report Date
    March 19, 2018
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AS NO CUSTOMER MATERIAL WAS RECEIVED, THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. THE TEST STRIPS WERE NOT RETURNED. HUMAN BLOOD SAMPLES FROM WARFARIN DONORS WERE USED. DONOR 1 INR: 2.2 INR. DONOR 2 INR: 2.5 INR. DONOR 1 HCT: 48%. DONOR 2 HCT: 48%. TESTING RESULTS: DONOR 1: RETENTION METER WITH MASTERLOT STRIPS: 2.2 INR. CUSTOMER METER WITH MASTERLOT STRIPS: 2.2 INR. DONOR 2: RETENTION METER WITH MASTERLOT STRIPS: 2.5 INR. CUSTOMER METER WITH MASTERLOT STRIPS: 2.5 INR. RESULTS: ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATIONS. REVIEW OF THE METER MEMORY COULD NOT CONFIRM THE ALLEGED RESULTS OF 6.7 ON (B)(6) 2018. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL (B)(4) FOR ONE PATIENT. (B)(6). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2-3 INR. THE PATIENT WAS ANEMIC WITH A HEMATOCRIT OF 32% ON (B)(6) 2017. THE PATIENT HAD NO ANTIPHOSPHOLIPID ANTIBODIES, NO HEPARIN, NO DIRECT THROMBIN INHIBITORS, AND NO BRUISING. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. NO STRIPS ARE AVAILABLE TO RETURN SINCE ALL WERE USED. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 244031-14) 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 PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912583 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403114

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR