BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1628428 · Received March 2, 2010

    Report

    Report Number
    2027969-2010-00251
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: DATE: (B)(6) 2010, INRATIO: 4.8, REFERENCE: 3.4, MEAN: 4.10, CONFIDENCE LIMITS: 2.3-5.7; (B)(6) 2010, 1.6, 2.8, 2.20, 1.4-3.1. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NO CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 10, 1ST INR: 4.8, 2ND INR: 1.6, MEAN: 3.20, SD: 2.26, %CV: 70.71. SINCE 70.71% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2/3/10, INRATIO: 3.3, REFERENCE: 2.8, MEAN: 3.05, CONFIDENCE LIMITS; 1.8-4.2; (B)(6) 2010, 2.2, 2.8, 2.50, 1.6-3.4. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2010, 1ST INR: 3.3, 2ND INR: 2.2, MEAN: 2.75, SD: 0.78, % CV: 28.28. SINCE 28.28 % CV IS MORE THAN 20% , THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. INR REPORTED DID NOT MEET PRECISION CRITERIA. PREVIOUS INVESTIGATION ON STRIP LOT #221726 FROM A PREVIOUS CASE REVEALED NO DISCREPANT RESULTS ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED. CONCLUSION: DATA ANALYSIS OF CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED PRECISION CRITERIA WAS NOT MET. NO PRODUCT IS EXPECTED TO BE RETURNED. PRECISION TEST RECORD FROM A PREVIOUS COMPLAINT INDICATED PRODUCT DEFICIENCY WAS NOT ESTABLISHED IN RETAIN STRIPS (LOT# 221726). THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 02/26/2010, 6 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #221726 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: INRATIO: 4.8, INRATIO (REPEAT): 1.6, LAB: 3.4; 3.3, 2.2, 2.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 221726

    Patients

    Seq Age Sex Outcome Treatment
    1