BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8095067 · Received November 21, 2018

    Report

    Report Number
    1823260-2018-04458
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 4, 2018
    Report Date
    December 28, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    RETENTION TEST STRIPS (244033) WERE TESTED IN COMPARISON TO MASTERLOT #28632180 (RECALIBRATED LOT TO RTF/09) ON INTERNAL REFERENCE METERS. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL AS TESTED COMPLIES WITH SPECIFICATION. THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    A PHARMACIST STATED THAT ONE PATIENT RECEIVED AN ERRONEOUS RESULT WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 10:30 A.M., A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 7.5 INR. IMMEDIATELY AFTERWARDS, THE PATIENT WAS TESTED AGAIN WITH THE METER AND THE RESULT WAS 7.6 INR. AT 3:30 P.M., A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING AS 4.93 INR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S THERAPEUTIC RANGE IS 2.5 - 3.5 INR. THE PATIENT HAS NOT HAD ANY CHANGES IN DIET. THE METER HAS BEEN USED BY THE PHARMACY FOR 2 YEARS. CONTROLS WERE NEVER TESTED ON THE METER. THE PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936288 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403314

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR AORTIC VALVE| COUMADIN| DIABETES MEDICATION| HIGH BLOOD PRESSURE MEDICATION| AORTIC VALVE| COUMADIN| DIABETES MEDICATION| HIGH BLOOD PRESSURE MEDICATION