BEUDAMED
    FDA Adverse Event Death Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1936126 · Received December 22, 2010

    Report

    Report Number
    1823260-2010-07631
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). CALLER DID NOT KNOW WHICH STRIP LOT PRODUCED THE DISCREPANT RESULT. LOTS 20173334 (EXPIRATION DATE 10/31/2010) AND 20169933 (EXPIRATION DATE 07/31/2010) WERE IN USE BY THE PATIENT AT THE TIME OF THE EVENT. THE RETENTION STRIPS FOR LOT 20173334 WERE TESTED ON A RETENTION METER. NO ERROR MESSAGES OCCURRED AND THE RETENTION STRIPS PERFORMED AS EXPECTED. RETENTION TESTING FOR LOT 20169933 WAS NOT POSSIBLE BECAUSE THE LOT WAS EXPIRED AT THE TIME OF THE EVENT. THE FIELD REPRESENTATIVE WENT TO THE HOSPITAL TO ATTEMPT TO OBTAIN MORE INFORMATION REGARDING THE PATIENT AND THE DEVICE. THE FIELD REPRESENTATIVE WAS ABLE TO GATHER SOME INFORMATION SUCH AS THE STRIP LOTS THE PATIENT WAS USING, BUT WAS NOT ABLE TO GATHER ANY FURTHER CLINICAL INFORMATION. FURTHER ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT HAVE BEEN UNSUCCESSFUL TO DATE. THERE IS LIMITED CLINICAL DATA REGARDING THIS PATIENT AND THE SEQUENCE OF EVENTS. WITHOUT KNOWING MORE ABOUT THE SEQUENCE OF EVENTS (E.G. THE DATES WHEN THE MEASUREMENTS WERE TAKEN AND THE THERAPY PATIENT RECEIVED), IT IS NOT CLEAR IF AND/OR HOW THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    CALLER STATES PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2010 FOR REASONS NOT SPECIFIED. THE PATIENT HAD REPORTED AN INR OF 2.5 OBTAINED ON THE COAGUCHEK XS SYSTEM PRIOR TO HOSPITAL ADMISSION. NO DATE OR TIME IS PROVIDED FOR THIS RESULT. THE PATIENT HAD OBTAINED THIS RESULT AT HOME, WHILE USING TWO VIALS OF TEST STRIPS, ONE WHICH HAD EXPIRED IN (B)(6) 2010. IT WAS NOT PROVIDED WHICH STRIP LOT PRODUCED THE REPORTED RESULT. IT WAS REPORTED THAT A LAB VALUE OF 1.7 INR WAS OBTAINED AT THE HOSPITAL AT SOME TIME AFTER THE ADMISSION; INFORMATION IS NOT PROVIDED AS TO DATE AND TIME OF THE 1.7 INR FROM THE HOSPITAL LAB. INFORMATION WAS PRESENTED THAT THE PATIENT PASSED AWAY (B)(6) 2010 DUE TO "DYSFUNCTION OF 'AORTIC' CAUSED BY THROMBUS." NO DETAILS HAVE BEEN PROVIDED REGARDING THE PATIENT'S TARGET INR RANGE OR THE REASON FOR ANTICOAGULATION THERAPY. IT WAS NOTED THAT THE PATIENT HAD MANY "CO-EXISTING DISEASES" AS WELL, BUT NONE WERE SPECIFIED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR Death