BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8125676 · Received December 3, 2018

    Report

    Report Number
    1823260-2018-04591
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    October 30, 2018
    Report Date
    December 3, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    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 · 1

    OCCUPATION IS LAY USER/PATIENT. THE CUSTOMER DID NOT RETURN THE TEST STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS ON COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNSPECIFIED LABORATORY METHOD. THE CUSTOMER ALLEGED 3 RESULTS FROM THE METER AT 9:30 A.M. OF 4.0 INR (DISPLAYED IN THE METER MEMORY), 6.0 INR (WRITTEN IN THE CUSTOMER'S LOG BOOK) AND 6.2 INR (WRITTEN IN THE CUSTOMER'S LOG BOOK). THE CUSTOMER USED A NEW FINGER FOR EACH METER TEST. THE LABORATORY RESULT WITHIN 7 HOURS OF THE METER RESULTS WAS 3.0 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 3.0 - 4.0 INR. THE CUSTOMER WAS ADVISED TO SKIP HER COUMADIN/WARFARIN DOSE FOR 3 DAYS BASED ON THE METER RESULTS. THE CUSTOMER HAD SOME UNUSUAL BLEEDING AND BRUISING AT THE TIME OF THE METER RESULTS; HOWEVER, NO MEDICAL TREATMENT WAS NECESSARY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER IS CURRENTLY "OKAY." THE CUSTOMER IS NOT ANEMIC AND DOES NOT HAVE ANTI-PHOSPHOLIPID ANTIBODIES. THE CUSTOMER IS NOT ON HEPARIN OR OTHER DIRECT THROMBIN INHIBITORS. THE CUSTOMER IS NOT TAKING ANY NEW MEDICATIONS, HAS NOT HAD ANY DIET CHANGES AND HAS NOT BEEN ILL RECENTLY. THE METER WAS REQUESTED FOR INVESTIGATION. THE CUSTOMER TOOK THE TEST STRIPS TO HER DOCTOR'S OFFICE AND HE USED THEM ON HIS METER. THE RESULTS FROM THE DOCTOR'S METER COMPARED WELL TO THE LABORATORY. NO SPECIFIC RESULTS WERE PROVIDED. THE METER WAS RETURNED. THE CUSTOMER DID NOT RETURN THE TEST STRIPS. THE RETURNED METER WAS TESTED USING QC MATERIAL AND MASTER LOT TEST STRIPS 286321: QC 1: 2.5 INR, QC 2: 2.5 INR, QC 3: 2.4 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION MASTER LOT STRIP LOT - QC LOT. (1.9 - 2.9 INR). ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WAS 4.0 %. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. RETENTION TEST STRIPS (LOT 266836) WERE TESTED IN COMPARISON TO MASTER LOT #28632180 (RECALIBRATED LOT TO RTF/09). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL COMPLIES WITH SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966661 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 26683623

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR