BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7788398 · Received August 16, 2018

    Report

    Report Number
    1823260-2018-02737
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 7, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S METER WAS RETURNED FOR INVESTIGATION. THE RETURNED METER WAS TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. HUMAN BLOOD SAMPLES FROM WARFARIN DONORS WERE USED. DONOR 1 INR: 4.1 INR, DONOR 2 INR: 2.4 INR. DONOR 1 HCT: 48%, DONOR 2 HCT: 42%. TESTING RESULTS: DONOR 1: RETENTION METER WITH MASTER LOT STRIPS: 4.1 INR, CUSTOMER METER WITH MASTER LOT STRIPS: 4.0 INR. DONOR 2: RETENTION METER WITH MASTER LOT STRIPS: 2.4 INR, CUSTOMER METER WITH MASTER LOT STRIPS: 2.4 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    OCCUPATION - THE OCCUPATION IS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S CAREGIVER COMPLAINED OF DISCREPANT INR RESULTS ON COAGUCHEK XS METER SERIAL (B)(4). AT 10:56 AM THE RESULT FROM THE METER WAS 3.6 INR. AT 10:59 AM THE RESULT FROM THE METER WAS 2.4 INR. AT 11:01 AM THE RESULT FROM THE METER WAS 2.5 INR. THE SAME FINGER WAS USED FOR ALL THREE MEASUREMENTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS "STABLE AND WELL". THE CUSTOMER WAS NOT TAKING HEPARIN, NO ANTIPHOSPHOLIPID ANTIBODIES, AND NO DIRECT THROMBIN INHIBITORS. THE CUSTOMER HAS HAD NO CHANGES IN DIET, NO ILLNESS, NO CHANGES IN MEDICATIONS, NO BLEEDING, AND NO BRUISING. THE CUSTOMER'S THERAPEUTIC RANGE WAS 2.0 - 3.0 INR. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 250322) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629801 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ALLOPURINOL| CHERRY FRUIT EXTRACT CAPSULES| COZAAR [LOSARTAN]| CRANBERRY CAPSULES| CYMBALTA [DULOXETINE]| IRON PILLS| LIPITOR [ATORVASTATIN]| METFORMIN| NIFEDIPINE| PAXIL| PROTONIX| TOPROL [METOPROLOL]| VESICARE [SOLIFENACIN]| VITAMIN D| WARFARIN| XANIX| ZANTAC[RANITIDINE]