BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6990702 · Received October 31, 2017

    Report

    Report Number
    1823260-2017-02483
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    September 7, 2017
    Report Date
    November 27, 2017
    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'S METER AND ONE TEST STRIP WERE RECEIVED FOR INVESTIGATION AND TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR INR: 2.2 INR AND 2.9 INR. DONOR HCT: 43% AND 37%. TESTING RESULTS: DONOR #1: MASTER LOT / CUSTOMER STRIP AND METER. 2.2 INR/ 2.2 INR. DONOR #2: MASTER LOT / CUSTOMER METER AND MASTER LOT. 2.9 INR/ 2.9 INR. ALL RESULTS WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MET THE SPECIFICATION. NONE OF THE GIVEN TREATMENTS/MEDICATIONS ARE CURRENTLY KNOWN TO INTERFERE WITH THE ACCURACY OF THE TEST RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE CUSTOMER TESTED TWICE A FEW MINUTES APART WITH RESULTS OF 1.7 INR AND 2.3 INR. HE STATED HIS WARFARIN DOSE HAD BEEN ADJUSTED PRIOR TO AND AFTER THESE RESULTS, BUT HE COULD NOT RECALL THE SPECIFIC ADJUSTMENTS THAT WERE MADE. THE CUSTOMER DID NOT REQUIRE MEDICAL TREATMENT DUE TO ANY OF THE RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER HAD A NEW MEDICATION AND PREVIOUSLY WAS NOT EATING AS MUCH VEGETABLES AS USUAL. HE STATED THE PREVIOUS WEEKEND HE BEGAN EATING MORE VEGETABLES AND THE NEW MEDICATION WAS RELATED TO HIS INR, BUT HE DID NOT KNOW WHAT IT WAS FOR SPECIFICALLY. THE CUSTOMER DID NOT HAVE ISSUES WITH HIS HEMATOCRIT, LUPUS, OR ANTIPHOSPHOLIPID ANTIBODIES. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 223855-22) 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 SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770217 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385522

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR