BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7248258 · Received February 7, 2018

    Report

    Report Number
    1823260-2018-00355
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 27, 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 CUSTOMER HAS NOT RETURNED ANY PRODUCT. SINCE NO PRODUCT WAS RETURNED, THE INVESTIGATION COULD NOT BE COMPLETED. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE DISCREPANT RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS INR RESULT ON A COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4). AT 6:49 AM THE METER RESULT WAS 1.0 INR. AT 6:52 AM THE METER RESULT WAS 8.0 INR. THE CUSTOMER DID NOT HAVE THEIR TREATMENT OR MEDICATION CHANGED BASED ON THE METER RESULTS. TWO DAYS LATER ON (B)(6) 2018 THE CUSTOMER HAD A VENOUS SAMPLE DRAWN AT THE DOCTOR'S OFFICE. USING A UNKNOWN TYPE OF METER AT THE DOCTOR'S OFFICE, THE CUSTOMER GOT A RESULT OF 5.5 INR. BASED ON THE RESULTS AT THE DOCTOR'S OFFICE, THE CUSTOMER HAD THEIR COUMADIN WITHHELD FOR 2 DAYS. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.2 - 3.0 INR. THE CUSTOMER HAS HAD NO DIET CHANGES OR NO ADDITIONAL ILLNESSES. THE CUSTOMER WAS NOT EXPERIENCING ANY UNUSUAL BLEEDING OR BRUISING AND IS TAKING NO NEW MEDICATIONS. THE CUSTOMER DOES NOT TAKE ANY DIRECT THROMBIN INHIBITORS, DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES, AND DOES NOT HAVE LUPUS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S CURRENT CONDITION WAS PROVIDED AS OKAY. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92480 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR OMEGA-3| PENTIBROXIL| VITAMINS| WARFARIN