BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5297865 · Received December 15, 2015

    Report

    Report Number
    1823260-2015-06037
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Date of Event
    November 22, 2015
    Report Date
    January 26, 2016
    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

    THE CUSTOMER RETURNED A VIAL OF STRIP LOT 233433, EXP.7/16 WITH 1 USED STRIP IN THE VIAL. THAT STRIP WAS NOT USED FOR ANY EVALUATION. THE CUSTOMER ALSO RETURNED A COAGUCHEK XS METER (SERIAL NUMBER (B)(4)). THAT METER AND A REFERENCE METER WAS TESTED WITH THE CURRENT MASTER LOT. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED HE IS GETTING ERRATIC RESULTS ON HIS COAGUCHEK XS (SERIAL NUMBER (B)(4)). HE REPORTED THAT ON (B)(6) 2015 HE TESTED 6.5 INR ON HIS METER AND WHEN HE REPEATED THE TEST ON A NEW FINGER HE OBTAINED A RESULT OF 1.1 INR. BOTH RESULTS WERE OUTSIDE OF HIS THERAPEUTIC RANGE OF 2.5-3.5 INR. HIS CURRENT CONDITION IS FINE. HE DID NOT CALL HIS DOCTOR WITH THE RESULTS BUT INSTEAD HELD HIS COUMADIN FOR ONE NIGHT ON HIS OWN. HE HAS NO KNOWN HEMATOCRIT ISSUES. HE IS NOT ON HEPARIN OR ANY DIRECT THROMBIN INHIBITORS. HE DOES NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. THE RETURN OF THE SUSPECT DEVICE WAS REQUESTED BUT THERE ARE NO STRIPS LEFT TO RETURN SO HE WAS REQUESTED TO RETURN THE EMPTY VIAL. REPLACEMENT PRODUCT WAS SENT TO THE CUSTOMER. RETENTION TESTING WAS DONE WITH STRIP LOT 23343321. NO ERROR MESSAGES OCCURRED AND THE RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827806 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23343321

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR