BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® S SYSTEM

    MDR report key: 1920628 · Received December 13, 2010

    Report

    Report Number
    1823260-2010-07374
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE COAGUCHEK S SYSTEM USED. (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/COAGUCHEK S RESULTS WERE OBTAINED: >3.2 INR/4.4 INR; 2.3 INR/1.6 INR. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. CALLER STATES THAT HE NO LONGER HAS THE STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1