BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7309150 · Received March 2, 2018

    Report

    Report Number
    1823260-2018-00631
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 13, 2018
    Report Date
    June 4, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    UPON REVIEW OF THE METER MEMORY, THE COMPLAINED VALUES ARE ALL DATED (B)(6) 2000. THERE WAS ALSO AN ADDITIONAL VALUE OF 1.1 INR AT 12:27 ON THE DATE (B)(6) 2000. THE FOLLOWING DISCREPANT VALUES WERE ALSO OBSERVED ON A DIFFERENT DATE: A VALUE OF 1.7 INR ON (B)(6) 2017 AT 12:32. A VALUE OF 2.5 INR ON (B)(6) 2017 AT 12:34.

    Additional Manufacturer Narrative · 0

    THE METER WAS RETURNED FOR INVESTIGATION. THE RETURNED METER WAS MEASURED WITH THE RETENTION TEST STRIPS 244034 IN COMPARISON TO THE CURRENT TEST STRIP MASTER LOT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. TESTING RESULTS: MARCUMAR 3: REFERENCE METER AND MASTER LOT STRIPS: 3.9 INR, CUSTOMER METER AND RETENTION STRIPS: 3.5 INR. MARCUMAR 4: REFERENCE METER AND MASTER LOT STRIPS: 3.6 INR, CUSTOMER METER AND RETENTION STRIPS: 2.9 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 20%.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED ERRONEOUS RESULTS WHEN TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 11:04 A.M., A CAPILLARY BLOOD SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 3.8 INR. AT 11:09 A.M., A CAPILLARY BLOOD SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 1.7 INR. AT 11:17 A.M., A CAPILLARY BLOOD SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 4.0 INR. EACH SAMPLE WAS COLLECTED FROM A DIFFERENT FINGER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S THERAPEUTIC RANGE IS 1.0 - 3.0 INR. THE PATIENT IS TESTED DAILY IN ORDER TO MAKE MEDICATION ADJUSTMENTS. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034) WERE TESTED IN COMPARISON WITH THE MASTER LOT TEST STRIPS. 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
    154185 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403411

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR ALDACTONE (1/2 - ONCE DAILY)| COUMADIN (AS REQUIRED)| FUROSEMID (1/4 - 3X DAILY)| LASIX (2X DAILY)| REVATIO JUICE (3X DAILY)