BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1792121 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04733
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS THAT DURING REFRACTIVE SURGERY, THE PT WAS NOT ABLE TO SEE THE FIXATION LIGHT. THE PROCEDURE ON BOTH EYES WAS COMPLETED THAT DAY. AT ONE DAY POST-OP, UCVA ON BOTH RIGHT AND LEFT EYE OF THIS PT WAS 20/20. THE SURGEON HAS NO CONCERNS FOR THIS PT'S OUTCOME.

    Description of Event or Problem · 1

    CALLER STATES THAT SHE TESTED 3.2 INR ON THE COAGUCHEK XS SYSTEM AND 2.4 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20180123

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR MULTIVITAMIN| LEVOXYL| "SYROID EXTRNET"| TESTOSTERONE| SIMVASTATIN| NEXIUM| METOPROLOL| COUMADIN (DAILY)