BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8221704 · Received January 7, 2019

    Report

    Report Number
    1823260-2019-00065
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    October 10, 2018
    Report Date
    January 17, 2019
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S METER WAS RETURNED FOR INVESTIGATION. THE RETURNED METER WAS MEASURED WITH MASTER LOT STRIPS IN COMBINATION WITH MASTER LOT STRIPS. TESTING RESULTS: QC 1: 2.5 INR , QC 2: 2.4 INR , QC 3: 2.4 INR . THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION MASTER LOT STRIP LOT - QC LOT. (1.9 - 2.9 INR). ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WAS 4.2%. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. RELEVANT RETENTION TEST STRIPS (LOT 250322) 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. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED.

    Additional Manufacturer Narrative · 1

    OCCUPATION - THE OCCUPATION IS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE PATIENT STATED SHE RECEIVED AN ERRONEOUS RESULT WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). A SAMPLE WAS COLLECTED FROM THE PATIENT AT 1:30 P.M. AND TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING WITH A VALUE OF 3.1 INR. AROUND 2:30 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 4.2 INR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT DID NOT RECEIVE A CHANGE IN MEDICATION BASED ON THE METER RESULT. THE PATIENT'S CURRENT CONDITION IS TIRED, FINE, GETTING A COLD, OKAY. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. THE PATIENT'S TESTING FREQUENCY IS ONCE PER WEEK. THE PATIENT IS NOT ANEMIC OR POLYCYTHEMIC. THE PATIENT DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES OR LUPUS. THE PATIENT DOES NOT TAKE HEPARIN OR DIRECT THROMBIN INHIBITORS. THE PATIENT DID NOT HAVE CHANGES MADE TO WARFARIN MEDICATION AROUND THE TIME OF THE EVENT. THE PATIENT DOES NOT TAKE ANY NEW MEDICATIONS, HAS HAD NO CHANGES IN DIET, AND HAS NO NEW ILLNESSES. THE PATIENT HAD SOME BRUISING, BUT DID NOT NEED MEDICAL TREATMENT. 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
    14853 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR BUPROPION| CITALOPRAM| GEMFIBROZIL| LORAZEPAM| TIZANIDINE| TRAZODONE| WARFARIN| BUPROPION| CITALOPRAM| GEMFIBROZIL| LORAZEPAM| TIZANIDINE| TRAZODONE| WARFARIN