BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1566536 · Received December 4, 2009

    Report

    Report Number
    2027969-2009-01135
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    November 7, 2009
    Report Date
    December 3, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED FOR STRIP LOT 213040A: INRATIO: 4.7; REFERENCE: 3.1; MEAN: 3.90; CONFIDENCE LIMITS: 2.3-5.7. INRATIO: 5.0; REFERENCE: 3.1; MEAN: 4.05; CONFIDENCE LIMITS: 2.3-5.7. INRATIO PRECISION DATA PROVIDED BY END-USER FOR STRIP LOT 213040A: 1ST INR: 4.7; 2ND INR: 5.0; MEAN: 4.85; SD: 0.21; %CV: 4.37. SINCE 4.37 % CV IS LESS THAN 20% , INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED FOR STRIP LOT 214533: INRATIO: 3.7; REFERENCE: 3.1; MEAN: 3.40; CONFIDENCE LIMITS: 2.0-5.0. MEAN AND CV% CALCULATIONS FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. AND PRECISION CRITERIA WAS MET. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. RE-TEST VALUE WITH TS WAS VALID. IT WAS INDICATED THAT POSSIBLE TESTING TECHNIQUE MAY HAVE AFFECTED TEST RESULTS. METER AND STRIPS WERE NOT EXPECTED TO BE RETURNED. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. AS OF 11/24/2009, EIGHTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 2130040 YIELDING A COMPLAINT RATE OF 0.005%. 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. 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: STRIP LOT #213040A. DATE: (B)(6)2009; INRATIO: 4.7, 5.0; LAB: 3.1, 3.1. STRIP LOT #214533. DATE: (B)(6)2009; INRATIO: 3.7; LAB: 3.1. CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS FOR STRIP LOT #213040A: DATE: (B)(6)2009; INR: 4.7, 5.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 213040A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI