BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 10953682 · Received December 5, 2020

    Report

    Report Number
    1823260-2020-03101
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 30, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D9 AND H3 WERE UPDATED. THE CUSTOMER'S METER AND TEST STRIPS WERE RETURNED FOR INVESTIGATION WHERE THEY WERE TESTED USING RETENTION CONTROLS IN COMPARISON WITH RETENTION TEST STRIPS. TWO TEST STRIP VIALS (SAME LOT 449506-11) WERE RETURNED (VIAL NO. 141162 AND 131620) TESTING RESULTS (QC RANGE = 2.5 - 3.1 INR): RETURNED VIAL NUMBER: 141162 QC 1: 2.8 INR, QC 2: 2.8 INR, QC 3: 2.8 INR, RETENTION STRIPS LOT: 449506-10 QC 1: 2.91 INR, QC 2: 2.9 INR, QC 3: 2.8 INR, TESTING RESULTS (QC RANGE = 4.1 ¿ 6.8 INR): RETURNED VIAL NUMBER: 131620 QC 1: 5.2 INR, QC 2: 5.2 INR, QC 3: 5.1 INR, RETENTION STRIPS LOT: 449506-10 QC 1: 5.0 INR, QC 2: 5.0 INR, QC 3: 5.0 INR, ALL INR VALUES WERE WITHIN THE SPECIFIED TARGET RANGES, CONFIRMING THE FUNCTIONALITY OF THE COMPLAINED COAGUCHEK METER. NO ERROR MESSAGES OCCURRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED.   ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. OCCUPATION IS LAY USER/PATIENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A PROFESSIONAL COAGUCHEK DEVICE. THE DEVICE MODEL AND THE SERIAL NUMBER OF THE PROFESSIONAL DEVICE WERE NOT PROVIDED. THE RESULT ON THE PROFESSIONAL'S DEVICE WAS 3.0 INR. THE RESULT ON THE CUSTOMER'S METER WAS 4.0 INR. THE RESULTS WERE TAKEN 10 MINUTES APART. THE CUSTOMER'S THERAPEUTIC RANGE IS 2-3 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416528 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 44950611

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ACABADIO| BACLOPHEN| CORTIENENT| MARCUMAR| PREGABALIN 300