BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7132943 · Received December 20, 2017

    Report

    Report Number
    1823260-2017-03041
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 2, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    ONE VIAL OF TEST STRIP LOT 244034-11 CONTAINING >10 TEST STRIPS AND THE COAGUCHEK INRANGE 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 . FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. MASTER LOT /RETENTION METER: MARCUMAR 3: 2.6 INR, MARCUMAR 4: 2.7 INR. CUSTOMER STRIPS/CUSTOMER METER: MARCUMAR 3: 2.7 INR, MARCUMAR 4: 2.7 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 3.8%. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THEY RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK INRANGE METER SERIAL NUMBER (B)(4). THE COAGUCHEK INRANGE METER IS NOT SOLD NOR IS LIKE OR SIMILAR TO A PRODUCT SOLD IN THE UNITED STATES. THE INITIAL RESULT WAS 3.2 INR AND WITHIN FIVE MINUTES, THE REPEAT RESULT WAS 2.3 INR. THE TESTING WAS PERFORMED ON DIFFERENT FINGERS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 1.6-2.5 INR. RELEVANT RETENTION TEST STRIPS (LOT 244034-10) 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 AND RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915507 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403411

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR