BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1601111 · Received January 28, 2010

    Report

    Report Number
    2027969-2010-00116
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 28, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INR REPORTED DID NOT MEET ACCURACY CRITERIA. PER GENERAL DESCRIPTION, CUSTOMER STATED INCORRECT STRIP CODE WAS ENTERED ON UNIT WHEN USING STRIP LOT 220392. INVALID STRIP CODE COULD LEAD TO INACCURATE RESULTS, AS INDICATED ON USER GUIDE. PREVIOUS INVESTIGATION ON STRIP LOT 220392 FROM CASE# (B) (4) MEET ACCURACY CRITERIA. REFER TO INVESTIGATION ACTION FOR FURTHER DETAILS. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B) (6) 2010, INRATIO METER = 7.2 INR, REFERENCE = 1.4 INR, MEAN = 4.30, CONFIDENCE LIMITS = 2.4-6.1. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS IN COMPLAINT WERE NOT EXPECTED TO BE RETURNED. ACCURACY TEST RESULT FROM CASE# (B) (4) REVEALED RETURNED STRIPS TEST MET ACCURACY CRITERIA. THERE IS NO SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S TEST RESULT DISCREPANCY. AS OF 01/27/2010, 12 DISCREPANT RESULTS COMPLAINT WERE REPORTED FOR LOT# 220392 YIELDING A COMPLAINT RATE OF 0.003%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 7.2, LAB: 1.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220392

    Patients

    Seq Age Sex Outcome Treatment
    1