BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6449860 · Received March 31, 2017

    Report

    Report Number
    1823260-2017-00685
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 9, 2017
    Report Date
    April 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S TEST STRIPS WERE RETURNED FOR INVESTIGATION. THE TEST STRIPS AND VIAL DID NOT APPEAR TO SHOW ANY DEFECTS. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RELEVANT RETENTION TEST STRIPS (LOT 121346) AND THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. RESULTS: DONOR 1: MASTER LOT STRIPS WITH REFERENCE METER: 2.3 INR. CUSTOMER STRIPS WITH REFERENCE METER: 2.3 INR. DONOR 2: MASTER LOT STRIPS WITH REFERENCE METER: 2.2 INR. CUSTOMER STRIPS WITH REFERENCE METER: 2.2 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 0.0 INR. THE RETURNED CUSTOMER MATERIAL AND THE RETENTION MATERIAL ARE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENTS TESTED WITH A COAGUCHEK XS METER WHEN COMPARED TO RESULTS FROM AN UNKNOWN LABORATORY METHOD. THE METER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER THEN MEASURED 2 FINGERSTICK SAMPLES COLLECTED FROM THE CUSTOMER HIMSELF/HERSELF ON THE METER. MEASUREMENTS WERE OBTAINED FROM SAMPLES COLLECTED WITHIN SEVEN HOURS OF EACH OTHER. THE FIRST METER MEASUREMENT WAS 1.9 INR AND THE SECOND METER MEASUREMENT WAS 0.9 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S PRODUCT WAS REQUESTED FOR INVESTIGATION. THE CUSTOMER AGREED TO SEND THE TEST STRIPS, BUT REFUSED TO SEND THE METER. RELEVANT RETENTION TEST STRIPS (LOT 121346) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231767 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 121346-11

    Patients

    Seq Age Sex Outcome Treatment
    1