BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3800919 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03340
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 30, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER REPORTS BLEEDING WITH A RESULT OF 2.8 INR OBTAINED ON THE COAGUCHEK XS SYSTEM. SHE WAS TAKEN TO THE HOSPITAL SOMETIME FROM 1-3 HOURS LATER. IT IS NOT KNOWN IF HER INR WAS CHECKED AT THE HOSPITAL. SHE WAS TREATED WITH 5 UNITS OF BLOOD AND ORAL VITAMIN K. CALLER WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS AND RELEASED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER THE CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277992 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR Hospitalization| O VITAMIN D| OMEPRAZOLE| LYRICA| XANAX| ROPINIROLE| FIORICET| CYMBALTA| SIMVASTATIN| FUROSEMIDE| PROMETHAZINE| MECLIZINE| AMLODIPINE| PROAIR| ARTIFICIAL MITRAL VALVE| HYDROMORPHONE| COUMADIN| MONTELUKAST SODIUM