BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6490561 · Received April 13, 2017

    Report

    Report Number
    1823260-2017-00769
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 13, 2017
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT RETURN THE TEST STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS ON COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4). THE CUSTOMER TESTED INITIALLY ON THE METER AT 8:39 A.M. AND THE RESULT WAS 5.2 INR (THE METER MEMORY LISTS THIS RESULT WITH A TIME OF 8:36 A.M.). THE CUSTOMER RE-TESTED ON THE METER AT 8:41 A.M. USING A NEW FINGER AND THE RESULT WAS 2.4 INR. THE CUSTOMER REPORTED BOTH RESULTS TO HIS PHYSICIAN. THE CUSTOMER HAS NOT HEARD BACK FROM HIS PHYSICIAN. NO MEDICATION ADJUSTMENTS HAVE BEEN MADE. THE CUSTOMER¿S MOST RECENT TEST RESULT WAS 3.2 INR ON (B)(6) 2017. THE CUSTOMER¿S WARFARIN DOSE WAS DECREASED FROM 2MG TO 1MG BASED ON THIS RESULT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER IS CURRENTLY IN STABLE CONDITION. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE CUSTOMER IS NOT ANEMIC. THE CUSTOMER HAS NO ANTIPHOSPHOLIPID ANTIBODIES AND IS NOT ON HEPARIN THERAPY OR DIRECT THROMBIN INHIBITORS. THE CUSTOMER STARTED TAKING A NEW VITAMIN 3 WEEKS AGO. THE CUSTOMER HAS NOT HAD ANY CHANGES TO HIS DIET OR HAD ANY RECENT ILLNESSES. THE CUSTOMER DOES NOT HAVE ANY SYMPTOMS OF BLEEDING OR BRUISING. THE METER AND STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 152881-23) WERE TESTED 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 TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL WAS ACCEPTABLE. THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS MEASURED WITH MASTER LOT STRIPS 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: 2.7 INR. DONOR #2 INR: 2.2 INR. DONOR #1 HCT: 42%. DONOR #2 HCT: 37%. DONOR #1: MASTER LOT: 2.8 INR. DONOR #1: CUSTOMER'S METER AND MASTER LOT: 2.7 INR. DONOR #2: MASTER LOT: 2.2 INR. DONOR #2: CUSTOMER'S METER AND MASTER LOT: 2.2 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. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272474 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 15288123

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR ASPIRIN| FOLIC ACID| LORATADINE| METFORMIN| PRESERVATION AREDS 2| SIMVASTATIN| SOTALOL| VALSARTAN| VERAPAMIL| WARFARIN