BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2882551 · Received December 20, 2012

    Report

    Report Number
    1823260-2012-06469
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.3 INR/1.70 INR CALLER STATES THE VENOUS SPECIMEN WAS DRAWN FROM THE PATIENT'S HAND. NO ACTIONS TAKEN BASED ON DEVICE RESULT. 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 ROCHE DIAGNOSTICS NA 21432911

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR ADVAIR TWICE DAILY| LASIX DAILY| XANAX DAILY| ISOSORBIDE MONONITRATE/DAY| DUONEB DAILY| PRAVACHOL DAILY| DIGOXIN DAILY| SPIRONOLACTONE 2/DAY| METOPROLOL TWICE DAILY| COUMADIN DAILY| VITAMIN B12 INJECTION/MONTH| CLONAZEPAM DAILY