BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® S SYSTEM

    MDR report key: 2123218 · Received June 14, 2011

    Report

    Report Number
    1823260-2011-03249
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    April 22, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK S SYSTEM (LOT NUMBER 953A, EXPIRATION DATE 02/29/2012). (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/S RESULTS WERE OBTAINED: 2.3 INR/1.6 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CALLER HAS DISCARDED THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 953A

    Patients

    Seq Age Sex Outcome Treatment
    1