BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8073207 · Received November 15, 2018

    Report

    Report Number
    1823260-2018-04295
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 15, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    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 · 1

    OCCUPATION WAS LAY USER/PT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT FROM THE CUSTOMER'S METER WAS 2.2 INR. THE RESULT FROM HIS PHYSICIAN'S ROCHE PROFESSIONAL METER LATER IN THE DAY WAS 2.9 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE CUSTOMER STATED HE "MAKES TOO MANY RED BLOOD CELLS", BUT DID NOT KNOW HIS HEMATOCRIT. THE CUSTOMER HAD NO DIRECT THROMBIN INHIBITORS, NO HEPARIN THERAPY, NO LÚPUS, NO ANTIPHOSPHOLIPID ANTIBODIES, NO DOSE CHANGES, NO DIET CHANGES, NO NEW MEDS, NO NEW ILLNESSES, AND NO BLEEDING OR BRUISING. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. THE RETURNED METER WAS TESTED WITH COMPARABLE RETENTION TEST STRIPS AND QUALITY CONTROLS. ADDITIONAL MEASUREMENTS WERE PERFORMED WITH MASTER LOT #28632180 (RECALIBRATED LOT TO RTF/09). TESTING RESULTS: QC 1: 2.5 INR , QC 2: 2.5 INR , QC 3: 2.5 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 %. RETENTION TEST STRIPS (LOT 250322) WERE TESTED IN COMPARISON TO MASTER LOT #28632180 (RECALIBRATED LOT TO RTF/09). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL COMPLIES WITH SPECIFICATION. NO INFORMATION WAS PROVIDED THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914662 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR