BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1002704 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01404
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT 3: HEMATOCRIT: 34.7%. NO OTHER PATIENT INFORMATION PROVIDED. THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM. CALLER DID NOT REPORT WHICH STRIP LOT PRODUCED SPECIFIC RESULTS.

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S/COAGUCHEK XS RESULTS WERE OBTAINED: PATIENT 1) 1.6 INR/2.1 INR. PATIENT 2) 1.3 INR/1.8 INR. PATIENT 3) 1.7 INR/2.4 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS - GJS GJS ROCHE DIAGNOSTICS 20154731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK