BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7435926 · Received April 17, 2018

    Report

    Report Number
    1823260-2018-01186
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 17, 2018
    Report Date
    May 17, 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 · 0

    CUSTOMER RETURNED METER AND STRIPS FOR INVESTIGATION. THE RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A REFERENCE METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. TESTING RESULTS: MARCUMAR 3: REFERENCE METER WITH MASTERLOT STRIPS: 2.8 INR, CUSTOMER METER WITH CUSTOMER STRIPS: 2.6 INR. MARCUMAR 4:: REFERENCE METER WITH MASTERLOT STRIPS: 3.4 INR, CUSTOMER METER WITH CUSTOMER STRIPS: 3.1 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 9 %. RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER'S SON STATED THEY RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT AT 10:10 AM WAS 4.3 INR AND THE RESULT AT 10:18 AM WAS 2.6 INR. THE CUSTOMER USED DIFFERENT FINGERS FOR THE TESTS. THE CUSTOMER WAS NOT HARMED AND DID NOT GO TO THE HOSPITAL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER HAD NO HEPARIN. THE HEMATOCRIT WAS NOT KNOWN. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244033) 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. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279112 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403311

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR MARCUMAR| METOPROLOL| RAMIPRIL| THORASEMIDE