BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7159614 · Received January 3, 2018

    Report

    Report Number
    1823260-2018-00036
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    November 13, 2017
    Report Date
    January 23, 2018
    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 · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER AND TEST STRIPS WERE RETURNED FOR INVESTIGATION. THE TEST STRIP VIAL SHOWED NO DEFECTS AND THE METER APPEARED UNDAMAGED AND CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER IN COMPARISON TO THE CURRENT MASTER LOT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR 1 RESULTS: MASTER LOT AND REFERENCE METER: 2.6 INR; CUSTOMER STRIPS AND CUSTOMER METER: 2.8 INR. DONOR 2 RESULTS: MASTER LOT AND REFERENCE METER: 2.7 INR; CUSTOMER STRIPS AND CUSTOMER METER: 2.8 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 7%. THE RETURNED CUSTOMER MATERIAL AND THE RETENTION MATERIAL ARE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT SHE RECEIVED ERRONEOUS RESULTS WHEN TESTING WITH COAGUCHEK INRANGE METER SERIAL NUMBER (B)(4). ON (B)(6) 2017, A VENOUS SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED WITH THE SIEMENS INNOVIN TEST METHOD, RESULTING AS 1.9 INR. AT THE SAME TIME, THE VENOUS BLOOD WAS TESTED ON THE METER, RESULTING WITH A VALUE OF 2.7 INR. ON THE MORNING OF (B)(6) 2017, A VENOUS SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED WITH THE SIEMENS INNOVIN TEST METHOD, RESULTING AS 1.5 INR. TWO HOURS LATER ON (B)(6) 2017, A CAPILLARY BLOOD SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON THE METER, RESULTING AS 2.7 INR. ALTHOUGH THE PATIENT STATED THAT THE METER MEASUREMENT TOOK PLACE TWO HOURS LATER, THE METER MEMORY INDICATES THAT THE 2.7 INR VALUE WAS MEASURED AT 17:58 ON (B)(6) 2017. BOTH METER RESULTS WERE REPORTED TO THE PATIENT AND HER DOCTOR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S THERAPEUTIC RANGE IS 2.5 - 3.5 INR. THE PATIENT'S HEMATOCRIT IS 33.5 (NO UNIT OF MEASURE PROVIDED). THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034-11) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5091 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403411

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR