BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7323375 · Received March 8, 2018

    Report

    Report Number
    1823260-2018-00721
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 19, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THEY RECEIVED QUESTIONABLE RESULTS 3 TIMES FROM THE COAGUCHEK XS METER SERIAL NUMBER (B)(4) AFTER GOING TO THE HOSPITAL FOR A 6-MONTH COMPARISON. THE INITIAL RESULT DOCUMENTED FROM THE METER MEMORY AT 12:59 FROM THE METER WAS 2.9 INR AND WAS PERFORMED BY THE CUSTOMER'S MOTHER. THIS WAS MEASURED WITH THE STRIP LOT NUMBER 22385313. THE RESULT FROM THE HOSPITAL'S COAGUCHEK XS PRO METER WAS 1.8 INR. THE NURSE PERFORMED QC AFTER THE RESULT WHICH WAS ACCEPTABLE. THE RESULT DOCUMENTED FROM THE METER MEMORY AT 13:06 FROM THE METER WAS 3.0 INR AND WAS PERFORMED BY THE CUSTOMER'S MOTHER USING A DIFFERENT FINGER. THIS WAS MEASURED WITH THE STRIP LOT NUMBER 22385313. THE RESULT FROM THE HOSPITAL'S COAGUCHEK XS PRO METER WAS 1.8 INR. THE BATTERIES WERE CHANGED AND A NEW LOT OF STRIPS WERE PREPARED FOR THE CUSTOMER'S METER. THE RESULT DOCUMENTED FROM THE METER MEMORY AT 13:13 FROM THE METER WAS 3.3 INR AND WAS PERFORMED BY THE CUSTOMER'S MOTHER USING A DIFFERENT FINGER. THIS WAS MEASURED WITH THE STRIP LOT NUMBER 25864313. THE RESULT FROM THE HOSPITAL'S COAGUCHEK XS PRO METER WAS 2.1 INR. THE HOSPITAL'S METER SERIAL NUMBER WAS NOT PROVIDED. THE HOSPITAL USED THEIR OWN STRIPS. THE STRIP LOT NUMBER AND EXPIRATION DATE THE HOSPITAL USED WAS ASKED FOR BUT NOT PROVIDED. THE CUSTOMER'S THERAPEUTIC RANGE WAS 2 - 3 INR. THE CUSTOMER HAS TAKEN WARFARIN AND OTHER MEDICATIONS FOR MANY YEARS WITHOUT A PREVIOUS INR DISCREPANCY. THE OTHER MEDICATIONS WERE NOT PROVIDED. RELEVANT RETENTION TEST STRIPS (LOT 223853-10 AND 258643-10) 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. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE. THE CUSTOMER'S RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. TESTING RESULTS: DONOR #1: MASTER LOT: 1.4 INR. DONOR #1: CUSTOMER METER AND STRIP: 1.6 INR. DONOR #2: MASTER LOT: 2.5 INR. DONOR #2: CUSTOMER METER AND STRIP: 2.6 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET THE SPECIFICATION. REFER TO THE MEDWATCH PATIENT IDENTIFIERS (B)(6) FOR THE TEST STRIPS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169259 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385313

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR