BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5510895 · Received March 18, 2016

    Report

    Report Number
    1823260-2016-00330
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    February 22, 2016
    Report Date
    June 2, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER AND THE STRIPS. THE TEST STRIPS AND VIAL DID NOT SHOW ANY DEFECTS. THE METER APPEARED UNDAMAGED AND CLEAR ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER IN COMPARISON WITH RELEVANT RETENTION TEST STRIPS (LOT 200781-10) AND THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). THE MAXIMUM DIFFERENCE BETWEEN THE MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 0.1 INR. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIES WITH THE SPECIFICATION. THE COMPLAINT HAS NOT BEEN SUBSTANTIATED. AFTER THE MEDWATCH WAS FILED IT WAS STATED THAT THE HOSPITAL METER WAS AN UNKNOWN POINT OF CARE DEVICE AND NOT A COAGUCHEK XS PLUS. THE HUSBAND HAD REPORTED IT WAS A COAGUCHEK XS PLUS AND THE CUSTOMER LATER CLARIFIED THAT IT WAS NOT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE CUSTOMER OBTAINED A RESULT OF 5.1 INR ON THE COAGUCHEK XS METER (SERIAL NUMBER (B)(4)). THE CUSTOMER WENT TO THE DOCTORS AFTER 1.5 HOURS AND THE RESULT OF THE DOCTOR METER WAS 3.7 INR. IT IS BELIEVED THAT THE DOCTOR METER WAS A COAGUCHEK XS PLUS (SERIAL NUMBER UNKNOWN). IT WAS REPORTED THAT THE SAMPLES WERE FROM TWO DIFFERENT FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166278 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 200781-12

    Patients

    Seq Age Sex Outcome Treatment
    1