BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3852873 · Received June 6, 2014

    Report

    Report Number
    1823260-2014-04085
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TESTED >8.0 INR AND >8.0 ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.6 INR. NO TREATMENT REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331021 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22119112

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR VITAMIN D| BENADRYL| LISINOPRIL| COUMADIN| AMBIEN| ARTIFICIAL KNEE| GABAPENTIN| OMEPRAZOLE| CALCIUM| PRAMIPEXOLE| HYDROCODONE