BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1002702 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01403
    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 FURTHER 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, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK