BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7376790 · Received March 28, 2018

    Report

    Report Number
    1823260-2018-00927
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 16, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S METER WAS RETURNED FOR INVESTIGATION. THE RETURNED METER AND MASTER LOT STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR 1 INR: 2.6 INR . DONOR 2 INR: 2.6 INR . DONOR 1 HCT: 44%. DONOR 2 HCT: 54%. TESTING RESULTS: DONOR 1: RETENTION METER WITH MASTER LOT STRIPS: 2.6 INR . CUSTOMER METER WITH MASTER LOT STRIPS: 2.6 INR. DONOR 2: RETENTION METER WITH MASTER LOT STRIPS: 2.6 INR. CUSTOMER METER WITH MASTER LOT STRIPS: 2.5 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATION. RELEVANT RETENTION TEST STRIPS LOT 250322-21 WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE NURSE STATED THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) AND ANOTHER ROCHE METER AT THE PHYSICIAN'S OFFICE. THE RESULT FROM THE PHYSICIAN'S ROCHE METER AT 4:24 OM WAS 2.3 INR. THE RESULT FROM THE CUSTOMER'S METER AT 4:56 PM WAS 3.1 INR. THE CUSTOMER WAS NOT ADVERSELY AFFECTED. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE CUSTOMER WAS NOT ANEMIC AND HAD NO ANTIPHOSPHOLIPID ANTIBODIES. THERE WERE NO CHANGES IN DIET, NO MEDICATIONS, AND NO RECENT ILLNESS. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220732 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN