BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8621035 · Received May 17, 2019

    Report

    Report Number
    1823260-2019-01874
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 17, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER AND TEST STRIPS WHERE THEY WERE TESTED USING RETENTION CONTROLS: TESTING RESULTS (QC RANGE = 2.6 - 4.0 INR): QC 1: 3.3 INR, QC 2: 3.3 INR, QC 3: 3.2 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT INR RESULTS FOR 1 PATIENT TESTED ON COAGUCHEK XS PROFESSIONAL METER WITH SERIAL NUMBER (B)(4). THE PATIENT WAS TESTED ON THE METER INITIALLY WITH A RESULT OF 7.4 INR. SINCE THIS RESULT WAS HIGH, THE PATIENT WAS RE-TESTED ON THE METER WITHIN 15 MINUTES AND THE RESULT WAS 5.4 INR. THE CUSTOMER THEN TOOK THE SAME LOT OF TEST STRIPS AND TESTED THE PATIENT ON A DIFFERENT COAGUCHEK XS METER AND THE RESULT WAS 7.5 INR. BASED ON THIS, THE CUSTOMER THOUGHT THE RESULTS OF 7.4 INR AND 7.5 INR WERE CORRECT AND WITHHELD THE PATIENT'S WARFARIN DOSE. THE PATIENT'S THERAPEUTIC RANGE IS 2. 0 - 3. 5 INR. THE CUSTOMER DISCARDED THE FIRST DROP OF BLOOD; THE CUSTOMER WAS ADVISED TO USE THE FIRST DROP OF BLOOD WHEN TESTING WITH A CAPILLARY SAMPLE. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE PATIENT IS FINE. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414677 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 34521511

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR BUSPIRON| FURSIMIDE| LISINOPRIL| TIMAZOPAM| WARFARIN