BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1860009 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-06016
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    October 5, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 6.7 INR ON THE COAGUCHEK XS SYSTEM AND 4.7 INR ON A COMPARISON LAB. THE CALLER SAID THAT BASED ON THE METER RESULT, THE DOCTOR HELD THE PATIENT'S COUMADIN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE IN (B)(6) 2007, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2L DAILY) AND PHYSIONEAL UNSPECIFIED PRODUCT (1.36% 5L DAILY AND 2.27% 7.5L DAILY) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY PERITONEAL EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL TREATMENT PER HOSPITAL PROTOCOL WITH CEFAZOLINE (125MG/L DAILY IP) AND CEFTAZIDIME (125MG/L DAILY IP). REMEDIAL TREATMENT WITH CEFAZOLINE AND CEFTAZIDIME WERE ONGOING. THE PATIENT RECOVERED FROM THE ABDOMINAL PAIN, AND THE PERITONEAL EFFLUENT WAS CLEAR. AT THE TIME OF REPORTING, THE PATIENT CONTINUED TREATMENT WITH CEFAZOLINE AND CEFTAZIDIME. EXTRANEAL AND PHYSIONEAL THERAPIES CONTINUED AT THE SAME DOSAGE. THE REPORTER COULD NOT ESTABLISH A CAUSAL ASSOCIATION OF THE PERITONITIS WITH EXTRANEAL AND PHYSIONEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20181231

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN