BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1892554 · Received November 3, 2010

    Report

    Report Number
    2027969-2010-01873
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 METER =1.2; REFERENCE =2.3; MEAN = 1.75; CONFIDENCE LIMITS = 1.2 - 2.3. DATE: (B)(6) 2010; INRATIO METER =2.0; REFERENCE =2.3; MEAN = 2.15; CONFIDENCE LIMITS = 1.4 - 3.1. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM 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. NO FURTHER INVESTIGATION IS REQUIRED. INRATIO PRECISION DATA PROVIDED BY END-USE LOT: DATE: (B)(6) 2010; 1ST INR = 1.2; 2ND INR = 2.0; MEAN = 1.6; SD = 0.57; %CV = 35.36. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT 234130 FROM ANOTHER COMPLAINT MET PRECISION CRITERIA. PRECISION WAS CALCULATED FROM ACCURACY TEST. (%CV OF DONOR 1= 2.93, %CV OF DONOR 2= 0.00). NO FURTHER INVESTIGATION REQUIRED. INVESTIGATION DETAILS FOLLOW: 2 THERAPEUTIC DONORS WERE TESTED USING RETAINED STRIPS, RETURNED (FROM PREVIOUS COMPLAINT), IN-HOUSE AND REFERENCE METERS. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND SYSMEX INRS ARE CALCULATED. AT LEAST (B)(4) REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 234130 ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0). NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA; NO FURTHER ACTION IS REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. PT'S CONDITION COULD NOT BE VERIFIED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. NO PRODUCT WAS EXPECTED TO BE RETURNED. REFERENCE RETAIN STRIP TEST RESULT COMPARISON MET PRECISION CRITERIA. AS OF 11/03/2010, 26 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT # 234130 YIELDING A COMPLAINT RATE OF 0.023%. 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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. 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:" DATE: (B)(6) 2010; INRATIO: 1.2 , 2.0; LAB: 2.3. THESE TESTS WERE ALL TAKEN WITHIN 1.5 HOURS OF EACH OTHER. PT'S DAUGHTER STATES HER MOTHER MIGHT HAVE A THYROID PROBLEM GOING ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1