BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16072853 · Received December 29, 2022

    Report

    Report Number
    1823260-2022-04237
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 8, 2022
    Report Date
    February 22, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702125100
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION IS PATIENT/CONSUMER. THE PATIENT'S METER WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE ON A COAGUCHEK XS METER. THE PATIENT ALLEGED THAT SHE GETS EITHER A 1.3 INR OR 3.1 INR EACH TIME SHE TESTS. UPON REVIEW OF THE METER MEMORY, THERE WAS ONLY ONE RESULT WITHIN THE LAST 5 THAT MATCHED THAT ALLEGATION (1.3 INR ON (B)(6) 2022). THE PATIENT ALLEGED THAT AFTER SHE GETS THE RESULTS THAT ARE THERE IN THE METER MEMORY, SHE POWERS THE METER OFF USING THE "I" BUTTON AND BACK ON, AND SHE WILL SEE A DIFFERENT RESULT IN THE RESULTS FIELD. THE PATIENT TURNED THE METER OFF USING THE "I" BUTTON AND THEN BACK ON. THE PATIENT ALLEGED A RESULT OF 2.1 DISPLAY WITH NO UNIT OF MEASURE (NO INR, SEC, OR %Q). A DISPLAY CHECK WAS PERFORMED. THE PATIENT CLEARLY READ THE THREE 8'S IN THE RESULTS FIELD. THERE WERE NO MISSING OR ABNORMAL SEGMENTS. ONCE THE "I" BUTTON WAS RELEASED AFTER THE DISPLAY CHECK, THE PATIENT SAW 2.1 ON THE SCREEN AGAIN WHERE THE THREE 8S HAD BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239261 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS COAGUCHEK XS PST NA 00365702125100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female