BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7863635 · Received September 11, 2018

    Report

    Report Number
    1823260-2018-03059
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 25, 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 · 0

    THE CUSTOMER RETURNED THE METER FOR INVESTIGATION. RETENTION TEST STRIPS WERE MEASURED WITH THE RETURNED METER USING LIQUID QC OF A HIGH LEVEL IN COMPARISON TO RE-CALIBRATED MASTERLOT ON INTERNAL REFERENCE METER. TESTING RESULTS: QQC 1: 2.4 INR, QC 2: 2.4 INR, QC 3: 2.4 INR. THE OBTAINED QC RESULTS WERE IN THE ALLOWED RANGE. NO ERROR MESSAGES OCCURRED DURING INVESTIGATION. THE CUSTOMER ALLEGATION HAS NOT BEEN SUBSTANTIATED AND NO PRODUCT PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 1

    OCCUPATION WAS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULTS FROM THE METER WITHIN A FEW HOURS OF EACH OTHER WERE 3.7 INR AND 2.5 INR. THE CUSTOMER USED TWO DIFFERENT FINGERS. THE CUSTOMER REPORTED THE RESULT OF 2.5 INR TO THE PHYSICIAN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE CUSTOMER HAD NO HEMATOCRIT ISSUES, NO DIRECT THROMBIN INHIBITORS, NO HEPARIN THERAPY, NO ANTIPHOSPHOLIPID ANTIBODIES, NO LUPUS, NO DOSE CHANGES, NO DIET CHANGES, NO NEW MEDICATIONS, NO NEW ILLNESSES, AND NO ABNORMAL BLEEDING OR BRUISING. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 281241) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704022 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 28124121 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR CARDIZEM| CYMBALTA| DIGOXIN| GABAPENTIN| LASIX| LYRICA| PRILOSEC| TRAVOSTATIN| ZITHROMAX| CARDIZEM| CYMBALTA| DIGOXIN| GABAPENTIN| LASIX| LYRICA| PRILOSEC| TRAVOSTATIN| ZITHROMAX