BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1619625 · Received February 18, 2010

    Report

    Report Number
    2027969-2010-00196
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 18, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 = 6.9 INR, REFERENCE = 5.0 INR, MEAN = 5.95. THE MEAN IS >5.0 AND THE DIFFERENCE IS LESS THAN 2.2. AND ONLY ONE INR VALUE IS GREATER THAN 5.0. THESE RESULTS ARE CONSIDERED ACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. 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 = 7.5 INR, REFERENCE = 4.9 INR, MEAN = 6.20. CUSTOMER REPORTED 7.5 INR. UPON INVESTIGATING METER'S MEMORY, 8.84 INR IS REGISTERED ON (B) (6) 2010. THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADDITIONAL INVESTIGATION IS REQUIRED. FUNCTIONAL TEST WAS PERFORMED. BOTH TESTS FAILED ON SAMPLE INDICATOR ON. DURING THERMOMETER SENSING TEST, LED INDICATOR SIMULTANEOUSLY EMITTED WITH "APPLY SAMPLE" MESSAGE. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER PLATE. ALL INR REPORTED ARE REGISTERED ON MEMORY AND FAILED THE ACCURACY CRITERIA. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT 220392. INVESTIGATION RESULTS: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 220392 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ONE SET OF INR VALUES IS INACCURATE TO COMPARE. ACCURACY TEST WAS PERFORMED WITH RETURNED METER AND STRIPS. TEST RESULT DID NOT REPRODUCE CUSTOMER'S OBSERVATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. THERE IS NO SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 02/17/2010, 15 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 220392 YIELDING A COMPLAINT RATE OF 0.004%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD 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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 6.9, LAB: 5.0. DATE: (B) (6) 2010, INRATIO: 7.5, LAB: 4.9.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization