BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS PT TEST 6 STRIP

    MDR report key: 21634516 · Received March 18, 2025

    Report

    Report Number
    1823260-2025-00770
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF METER A IS (B)(6). THE SERIAL NUMBER OF METER B IS (B)(6). THE CUSTOMER RECEIVED ERROR 8 FROM METER A. PRODUCT LABELING STATES: "ERROR: INTERNAL ERROR - AN ERROR OCCURRED DURING THE INTERNAL DIAGNOSTIC TEST. SOLUTION: TURN THE METER OFF AND REMOVE THE BATTERIES. WAIT AT LEAST 1 MINUTE BEFORE RE-INSERTING THE BATTERIES INTO THE BATTERY COMPARTMENT. RE-SET THE DATE AND TIME AS DESCRIBED IN THE METER SETUP SECTION OF THIS MANUAL. CAUTION: THE DATE AND TIME MUST BE SET CORRECTLY. REPEAT THE TEST. IF YOU SEE THE SAME ERROR MESSAGE AGAIN, THE METER HAS A DEFECT. CALL THE ROCHE CUSTOMER SUPPORT CENTER AT 1-800-428-4674." THE CUSTOMER STATED THE METER WOULD NOT POWER ON. PRODUCT LABELING STATES, "SUPPORT/SERVICES - QUESTIONS PLEASE CALL THE ROCHE CUSTOMER SUPPORT CENTER AT 1-800-428-4674 (MONDAY THROUGH FRIDAY FROM 7 AM TO 11 PM EST) IF YOU HAVE QUESTIONS REGARDING THE HANDLING OF YOUR METER, THE RELIABILITY OF YOUR RESULTS, OR IF YOU SUSPECT THE METER IS DEFECTIVE. IN CASE OF AN EMERGENCY, PLEASE CONTACT YOUR PHYSICIAN." THE PRODUCT HAS NOT BEEN RECEIVED FOR FURTHER INVESTIGATION AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ON A REGULAR BASIS, COAGUCHEK STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION. SECTION E3: OCCUPATION IS PATIENT/CONSUMER.

    Additional Manufacturer Narrative · 0

    METER B WITH SERIAL NUMBER (B)(6) WAS SUBMITTED FOR INVESTIGATION AND WAS TESTED USING RETENTION STRIPS AND RETENTION CONTROLS. LEVEL 1 TESTING RESULTS (QC RANGE = 1.0 - 1.4 INR): QC 1: 1.2 INR. LEVEL 2 TESTING RESULTS (QC RANGE = 2.4 - 3.6 INR): QC 2: 2.9 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. THE RESULT ALLEGED BY THE CUSTOMER WAS OBSERVED IN THE METER¿S RESULT MEMORY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM TWO COAGUCHEK XS METERS - METER A AND METER B. THE RESULT FROM METER A WAS 1.8 INR. THE CUSTOMER DOES NOT BELIEVE THIS RESULT. THE RESULT FROM METER B WAS 2.3 INR. THE TIME INTERVAL BETWEEN TESTS WAS NOT PROVIDED. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE CUSTOMER TESTS WEEKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593285 COAGUCHEK XS PT TEST 6 STRIP PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 77503323 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female AMIRON| ATORVASTATIN| FUROSEMIDE| JARDIANCE| LATANOPROST| PREDNISONE| WARFARIN