BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 10163421 · Received June 17, 2020

    Report

    Report Number
    1823260-2020-01481
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 17, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE REPORTER. THE REPORTER'S METER WAS PROVIDED FOR INVESTIGATION AND UPON INITIAL INVESTIGATION OF THE METER, THE METER COULD NOT BE POWERED ON DUE TO CORROSION. OCCUPATION - THE OCCUPATION IS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT HER COAGUCHEK XS METER SERIAL NUMBER (B)(4) WAS BEEPING. THE DISPLAY SHOWED "RRR" AND "JJJ" WAS ALSO VISIBLE IN THE UPPER RIGHT CORNER. A DISPLAY CHECK WAS PERFORMED AND THE METER BEEPED THREE TIMES SLOWLY AND THERE WAS AN "RRR" IN THE MIDDLE OF THE SCREEN. THE RESULTS FIELD OF THE DISPLAY HAD MISSING SEGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626485 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS XS PST NA

    Patients

    Seq Age Sex Outcome Treatment
    1