BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7177881 · Received January 10, 2018

    Report

    Report Number
    1823260-2018-00104
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 26, 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
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT'S METER WAS RETURNED FOR INVESTIGATION. UPON REVIEW OF THE METER MEMORY, THE FOLLOWING ADDITIONAL RESULT DISCREPANCIES WERE OBSERVED: ON (B)(6) 2013 AT 09:19, THE PATIENT HAD A RESULT OF 1.8 INR. ON (B)(6) 2013 AT 09:36, THE PATIENT HAD A RESULT OF 3.7 INR. ON (B)(6) 2016 AT 08:28, THE PATIENT HAD A RESULT OF 6.5 INR. ON (B)(6) 2016 AT 08:55, THE PATIENT HAD A RESULT OF 3.3 INR. ON (B)(6) 2017, THE PATIENT HAD AN ADDITIONAL METER VALUE OF 4.1 INR AT 08:51. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). 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. THE RETURNED METER WAS MEASURED WITH MASTER LOT STRIPS IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR 1 INR: 3.7 INR. DONOR 2 INR: 2.7 INR. DONOR 1 HCT: 47%. DONOR 2 HCT: 35%. TESTING RESULTS: DONOR #1: MASTER LOT: 3.7 INR; CUSTOMER METER AND MASTER LOT: 3.7 INR. DONOR #2: MASTER LOT: 2.7 INR; CUSTOMER METER AND MASTER LOT: 2.7 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THE PATIENT SAMPLES WERE ALWAYS IDENTIFIED AS BLOOD. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS. NONE OF THE TREATMENTS/MEDICATIONS PROVIDED TO THE PATIENT ARE CURRENTLY KNOWN TO INTERFERE WITH THE ACCURACY OF THE TEST RESULTS.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT HE RECEIVED ERRONEOUS RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). TESTING WAS PERFORMED WITH TWO DIFFERENT TEST STRIP LOT NUMBERS. AT 8:57 A.M., A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 4.1 INR. TEST STRIP LOT NUMBER 22385523 WAS USED AT THIS TIME. AT 1:02 P.M., A SAMPLE FROM A DIFFERENT FINGER OF THE PATIENT WAS TESTED ON THE METER, RESULTING AS 7.7 INR. TEST STRIP LOT NUMBER 25032221 WAS USED AT THIS TIME. THE PATIENT BELIEVED THE VALUE OF 4.1 INR TO BE CORRECT AND THE RESULT OF 7.7 INR TO BE INCORRECT. NO RESULTS WERE REPORTED TO THE DOCTOR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT WAS NOT TREATED BASED ON THE METER RESULTS. THE PATIENT'S THERAPEUTIC RANGE IS 2.5 - 3.5 INR. THE PATIENT'S TESTING FREQUENCY IS EVERY THREE WEEKS. THE PATIENT IS NOT ANEMIC AND DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT IS NOT ON HEPARIN THERAPY AND DOES NOT USE DIRECT THROMBIN INHIBITORS. THE PATIENT HAS NO CHANGES TO COUMADIN DOSE, NO RECENT ILLNESSES, OR NO NEW MEDICATIONS. THE PATIENT STATED THAT HE HAD SEVERAL BEERS ON (B)(6) 2017. THE PATIENT HAS HAD NO SYMPTOMS OF BLEEDING OR BRUISING. THE PATIENT DID NOT REMEMBER IF THE QUALITY CONTROL CHECK WAS DONE ON THE METER. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22933 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR