BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7163301 · Received January 4, 2018

    Report

    Report Number
    1823260-2018-00050
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 11, 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

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ONE VIAL OF TEST STRIPS AND THE COAGUCHEK INRANGE METER 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 (LOT 124158-80). 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: 2.9 INR; MARCUMAR 4: 2.8 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 10%. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK INRANGE METER SERIAL NUMBER (B)(4). (B)(6). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER USED A NEW FINGER FOR EACH TEST. THE THERAPEUTIC RANGE WAS 2.0-2.5 INR. THE METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034-10) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS. 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 COMPLIED WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8547 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 244034-11

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR