BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7181610 · Received January 11, 2018

    Report

    Report Number
    1823260-2018-00121
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    January 2, 2018
    Report Date
    February 7, 2018
    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)

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE MATERIAL WAS TESTED 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: 2.0 INR. DONOR #2 INR: 2.4 INR. DONOR #1 HCT: 44%. DONOR #2 HCT: 42%. DONOR #1: MASTER LOT: 2.0 INR. DONOR #1: CUSTOMER METER AND MASTER LOT: 1.9 INR. DONOR #2: MASTER LOT: 2.4 INR. DONOR #2: CUSTOMER METER AND MASTER LOT: 2.3 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. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED FOR THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED.

    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 AT 10:21 A.M. WITH A RESULT OF 5.9 INR. THE CUSTOMER TESTED 2 MORE TIMES AT 10:25 A.M. AND 10:34 A.M. WITH RESULTS OF 6.2 INR AND 4.2 INR RESPECTIVELY. THE CUSTOMER STATED THE RESULT OF 4.2 INR MAY HAVE BEEN FROM A FINGER THAT WAS ALREADY USED FOR A GLUCOSE TEST ON HIS BLOOD GLUCOSE METER. THE RESULTS OF 5.9 INR AND 6.2 INR WERE FROM DIFFERENT FINGERS. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2 ¿ 3 INR. NO ADVERSE EVENT OCCURRED. THE CUSTOMER HAS NOT RECEIVED ANY TREATMENT AND IS IN FINE CONDITION. THE CUSTOMER DOES NOT HAVE ANEMIA OR ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER DOES NOT TAKE HEPARIN. THE CUSTOMER DOES TAKE A DIRECT THROMBIN INHIBITOR (PLAVIX). THE CUSTOMER WAS NOT EXPERIENCING ANY BLEEDING OR BRUISING. THE CUSTOMER HAS NOT HAD CHANGES IN DIET OR MEDICATION. THE CUSTOMER WAS ON ANTIBIOTICS THE WEEK OF (B)(6) 2017. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25470 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR