BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® S SYSTEM

    MDR report key: 1812797 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05017
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE COAGUCHEK S SYSTEM USED. REFERENCE MEDWATCH REPORT WITH (B)(4) FOR THE COAGUCHEK XS SYSTEM USED.

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/COAGUCHEK S RESULTS WERE OBTAINED: 1.5 INR/2.4 INR; 2.3 INR/1.8 INR; 2.4 INR/1.8 INR; 2.1 INR/1.6 INR; 2.5 INR/2.0 INR; 3.8 INR/2.7 INR. NO 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

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 2. THE PATIENT'S DRAIN VOLUME WAS 2915ML. THE FILL VOLUME WAS 1500ML. THIS MEETS IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION COULD BE OBTAINED AND THE PATIENT COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 899A

    Patients

    Seq Age Sex Outcome Treatment
    1