BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 769443 · Received August 21, 2006

    Report

    Report Number
    1823260-2006-04650
    Event Type
    Malfunction
    Date Received
    August 21, 2006
    Report Date
    August 1, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER CALLED AND ALLEGED DISCREPANT RESULTS WHEN COMPARED TO THE LAB. THE REPORTED DEVICE RESULT WAS 4.8 INR ON 6/19/2006 AND 5.6 INR ON 6/22/2006 FOR ONE PATIENT. THE DEVICE RESULTS REPORTED FOR A SECOND PATIENT WERE 5.3 INR ON 7/11/2006 AND 6.0 INR ON 7/27/2006. THE CORRESPONDING LAB RESULTS REPORTED WERE 2.9 INR ON 6/19/2006, 3.6 INR ON 6/22/2006, 3.6 INR ON 7/11/2006 AND 4.7 INR ON 7/27/2006. NO TREATMENT WAS GIVEN TO THE PATIENTS. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 2

    THE REPORTER CALLED AND ALLEGED DISCREPANT RESULTS WHEN COMPARED TO THE LAB. THE REPORTED DEVICE RESULT WAS 4.8 INR ON 6/19/2006 AND 5.6 INR ON 6/22/2006 FOR ONE PATIENT. THE DEVICE RESULTS REPORTED FOR A SECOND PATIENT WERE 5.3 INR ON 7/11/2006 AND 6.0 INR ON 7/27/2006. THE CORRESPONDING LAB RESULTS REPORTED WERE 2.9 INR ON 6/19/2006, 3.6 INR ON 6/22/2006, 3.6 INR ON 7/11/2006 AND 4.7 INR ON 7/27/2006. NO TREATMENT WAS GIVEN TO THE PATIENTS. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME MONITOR JPA ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1
    2 76 YR VITAMINS| FLONASE| ZOCOR| DIAZAC| ADVAIR| ALLEGRA| COUMADIN