BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7650099 · Received June 29, 2018

    Report

    Report Number
    1823260-2018-02125
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 1, 2018
    Report Date
    August 31, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM THREE COAGUCHEK XS PRO METERS DURING METER TO LABORATORY COMPARISONS. THE LABORATORY USED DADE INNOVIN REAGENT. OF THE DATA PROVIDED, ONLY THE RESULTS FOR FOUR PATIENTS WERE DISCREPANT. THE SPECIFIC DATES OF TESTING WERE REQUESTED BUT WERE NOT PROVIDED. THE TESTING WAS SAID TO HAVE BEEN DONE "IN THE PAST 2 WEEKS". FROM METER SERIAL NUMBER (B)(4): PATIENT 1 RESULT FROM THE METER WAS 1.8 INR. THE RESULT FROM THE LABORATORY WAS 1.1 INR. PATIENT 2 RESULT FROM THE METER WAS 4.3 INR. THE RESULT FROM THE LABORATORY WAS 3.3 INR. FROM METER SERIAL NUMBER (B)(4): PATIENT 3 RESULT FROM THE METER WAS 2.0 INR. THE RESULT FROM THE LABORATORY WAS 1.1 INR. PATIENT 4 RESULT FROM THE METER WAS 4.3 INR. THE RESULT FROM THE LABORATORY WAS 3.3 INR. INFORMATION CONCERNING IF ANY RESULT WAS REPORTED TO A PERSON MAKING A TREATMENT DECISION OR IF ANY PATIENT WAS ADVERSELY AFFECTED WERE REQUESTED BUT IT WAS UNKNOWN. THE SUSPECT METERS AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 244034) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494420 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 244034-12

    Patients

    Seq Age Sex Outcome Treatment
    1