BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7333877 · Received March 13, 2018

    Report

    Report Number
    1823260-2018-00803
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 28, 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 · 0

    THE PATIENT'S METER WAS RETURNED FOR INVESTIGATION. 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: 4.2 INR. DONOR 1 HCT: 41%, DONOR 2 HCT: 40%. TESTING RESULTS: DONOR 1: RETENTION METER WITH MASTERLOT STRIPS: 2.8 INR, CUSTOMER METER WITH MASTERLOT STRIPS: 2.8 INR. DONOR 2: RETENTION METER WITH MASTERLOT STRIPS: 4.2 INR, CUSTOMER METER WITH MASTERLOT STRIPS: 4.2 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS ON COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE CUSTOMER INITIALLY TESTED ON THE METER WITH A RESULT OF 3.4 INR. THE CUSTOMER WASN'T SURE IF SHE HAD ENOUGH BLOOD AND RETESTED ON THE METER WITH A RESULT OF 2.7 INR. THE CUSTOMER RETESTED AGAIN AND GOT A RESULT OF 2.2 INR. THERE WAS APPROXIMATELY 5 MINUTES BETWEEN EACH TEST. THE CUSTOMER USED DIFFERENT FINGERS FOR THE RESULTS OF 3.4 INR AND 2.7 INR. THE CUSTOMER RE-TESTED ON THE FINGER THAT PRODUCED THE 3.4 INR RESULT AND OBTAINED THE RESULT OF 2.2 INR. THE CUSTOMER'S COUMADIN DOSE WAS NOT ADJUSTED BASED ON THESE RESULTS. THE CUSTOMER HAS BEEN ON A LOWER COUMADIN DOSE FOR THE LAST FEW WEEKS AS HER INR RESULTS HAVE BEEN HIGHER THAN NORMAL. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR. NO TREATMENT WAS NECESSARY. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS FINE. THE METER HAS NOT BEEN CLEANED; THE METER IS 1 MONTH OLD. THE CUSTOMER HAS HAD NO OTHER MEDICATION CHANGES OR ILLNESSES. THE CUSTOMER HAS HAD NO CHANGES TO HER DIET. THERE WERE NO CONCERNS WITH HCT LEVELS, LUPUS OR ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER IS NOT ON ANY DIRECT THROMBIN INHIBITORS. 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. 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
    177618 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR ASPIRIN| COUMADIN