BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5265125 · Received December 3, 2015

    Report

    Report Number
    1823260-2015-04679
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Date of Event
    November 12, 2015
    Report Date
    January 5, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE VIAL OF TEST STRIPS, LOT 200782 (VIAL #00170819 ), CONTAINING 4 TEST STRIPS. THE INVESTIGATION WITH THE CUSTOMER'S STRIPS AND A MASTER LOT OF STRIPS USING DONOR BLOOD SHOWED THAT ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RELEVANT RETENTION TEST STRIPS (LOT 20078221) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETENTION SAMPLES WERE ACCEPTABLE AND PERFORMED AS SPECIFIED.

    Description of Event or Problem · 1

    THE TRAINER WITH COAGUCHEK PATIENT SERVICES REPORTS OBTAINING A RESULT OF 5.3 INR ON HER TRAINING COAGUCHEK XS METER (SERIAL NUMBER (B)(4)) WHILE THE PATIENT'S COAGUCHEK XS METER (SERIAL NUMBER (B)(4)) SHOWED A RESULT OF 2.6 INR. BOTH TESTS WERE WITHIN MINUTES OF EACH OTHER AND A DIFFERENT FINGER WAS USED FOR EACH TEST. THE RESULT OF 2.6 INR WAS THE RESULT THAT WAS REPORTED TO COAGUCHEK PATIENT SERVICES. THE PATIENT IS FINE AT THIS TIME. THE PATIENT IS NOT ON HEPARIN OR ANY DIRECT THROMBIN INHIBITORS. IT IS NOT KNOWN IF THE PATIENT HAS ANY ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT DID NOT HAVE ANY BRUISING OR BLEEDING. THE PATIENT WAS NOT ON ANY SPECIAL DIET AND SHE HAD NOT EATEN ANY UNUSUAL DIET. THE PATIENT'S WARFARIN DOSE WAS NOT CHANGED AND HER LAST DOSE OF WARFARIN WAS 20 HOURS BEFORE THE RESULTS. THE THERAPEUTIC RANGE FOR THE PATIENT IS 2-3 INR. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND REPLACEMENT PRODUCT WAS SENT. THIS MEDWATCH IS FOR THE TRAINER'S METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793323 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20078221

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR