BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1723719 · Received June 4, 2010

    Report

    Report Number
    2027969-2010-00704
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 4, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 3.2, REFERENCE: 2.2, MEAN: 2.70, CONFIDENCE LIMITS: 1.7-3.8. DATA ANALYSIS REVEALED BOTH INRATIO AND LAB INR RESULTS REPORTED BY END USER MEET ACCURACY CRITERIA. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. CUSTOMER MILKING FINGER DURING SAMPLE COLLECTION COULD HAVE CONTRIBUTED TO THE INVALID INR TEST RESULTS. AS OF 06/02/2010, TWO DISCREPANT RESULT COMPLAINTS HAVE BEEN REPORTED FOR LOT# 232170 YIELDING A COMPLAINT RATE OF 0.001%. THIS IS BELOW ACTION THRESHOLDS (0.07%). NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6)2010, INRATIO: 3.2, LAB: 2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 232170

    Patients

    Seq Age Sex Outcome Treatment
    1 NI