BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1589213 · Received January 14, 2010

    Report

    Report Number
    2027969-2010-00042
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 14, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. PER GENERAL DESCRIPTION, 1.3 OR 1.4 AND 10 INR ARE OBTAINED MORE THAN A WEEK APART OF EACH OTHER. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO THE CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. CUSTOMER WAS MILKING THE FINGER. MILKING THE FINGER CAN CAUSE CONTAMINATION AS INDICATED ON TECHNICAL BULLETIN 107. THERE IS NO CLINICAL SIGNIFICANCE IN THE DISCREPANCY ANALYSIS FOR CUSTOMER DID NOT PROVIDE THE INRATIO VALUE AND LAB VALUE TO CALCULATE THE CONFIDENT LIMIT. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF END-USER'S DISCREPANCY. TRENDING AND TRACKING IS SUBJECT TO BE PERFORMED FOR STRIP LOT# 220392. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS ARE AS FOLLOWS: DATE: (B) (6) 2009; INRATIO: 1.3; LAB: -. DATE: (B) (6) 2009; INRATIO: -; LAB: 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220392

    Patients

    Seq Age Sex Outcome Treatment
    1