BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5765187 · Received July 1, 2016

    Report

    Report Number
    1823260-2016-00839
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 1, 2016
    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 · 1

    THIS EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHILE USING HER COAGUCHEK XS METER (SERIAL NUMBER (B)(4)) SHE OBTAINED A RESULT OF 3.7 INR AT 08:45 AM ON (B)(6) 2016 AND A RESULT OF 2.2 INR AT 09:00 AM ON (B)(6) 2016. A DIFFERENT FINGER PAD WAS USED FOR EACH TEST. IT WAS NOT KNOWN IF THE PATIENT REPORTED THE RESULTS TO HER DOCTOR. THE RESULTS IN HER METER WERE DOWNLOADED AND SHOW THAT ON (B)(6) 2001 SHE OBTAINED RESULTS OF 1.0 INR AND 2.0 INR. SHE WAS ASKED AND SHE CONFIRMED THAT THESE RESULTS WERE ALSO OBTAINED FROM SEPARATE FINGERS. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THESE RESULTS. CONFIRMATION OF THE ACTUAL DATES OF BOTH EVENTS WAS REQUESTED SINCE ALL OF THE RESULTS IN THE DATA DOWNLOAD SHOWED AS THE YEAR OF 2001. THE ACTUAL DATES COULD NOT BE CONFIRMED. HER THERAPEUTIC RANGE IS 2.2 - 2.5 INR. THERE WAS NO ADVERSE EVENT. THE STRIPS AND METER WERE RETURNED. THE TEST STRIPS AND VIAL DID NOT SHOW ANY DEFECTS. THE METER APPEARED UNDAMAGED AND CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER IN COMPARISON WITH RELEVANT RETENTION TEST STRIPS (LOT 203358-10) AND THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIES WITH SPECIFICATIONS. THERE WAS NO PRODUCT PROBLEM FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419637 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20353911

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR DEFIBRILLATOR