BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 16962320 · Received May 19, 2023

    Report

    Report Number
    1823260-2023-01690
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 30, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    04015630945689
    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

    THE METER WAS REQUESTED FOR INVESTIGATION AND A REPLACEMENT METER WAS SENT TO THE CUSTOMER. E3 - OCCUPATION: PATIENT/CONSUMER.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. PRODUCT LABELING STATES "IF YOUR DISPLAY IS NOT FUNCTIONING PROPERLY, DO NOT PERFORM FURTHER TESTS AS RESULTS MAY BE MISREAD IF A SEGMENT IS MISSING. CONTACT THE ROCHE CUSTOMER SUPPORT CENTER AT 1-800-428-4674 IN THIS CASE."

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK XS METER. THE REPORTER STATED THAT ON (B)(6) 2023 OR (B)(6) 2023, THE METER RESULT WAS 2.9 INR BUT THE METER RESULT WAS DIFFICULT TO READ AS THE SCREEN WAS FLICKERING AND THE DISPLAY WAS GOING FROM DARK TO LIGHT. THE METER NOW WOULD NOT POWER ON AT ALL EVEN AFTER THE BATTERIES WERE CHANGED. THE METER RESULT WAS REPORTED TO THE DOCTOR. ON TROUBLESHOOTING, A DISPLAY OR MEMORY CHECK COULD NOT BE PERFORMED BECAUSE THE METER WOULD NOT POWER ON AT ALL. THE THERAPEUTIC RANGE IS 2.5 TO 3.5 INR. THE REPORTER STATED THAT HIS DOCTOR LIKES HIS INR TO BE AT 2.9 TO 3.1 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623195 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS NA NA 04015630945689

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown