BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1942306 · Received December 22, 2010

    Report

    Report Number
    2027969-2010-02245
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. DATE: (B)(6) 2010. INRATIO METER = 4.1; REFERENCE = 3.0. MEAN = 3.55, CONFIDENCE LIMITS = 2.0 - 5.0. DATE: (B)(6) 2010, INRATIO METER = 4.2; REFERENCE = 3.0, MEAN = 3.6, CONFIDENCE LIMITS = 2.0 - 5.0. 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-USER LOT: DATE: (B)(6) 2010. 1ST INR = 4.1; 2ND = 4.2, MEAN = 4.15; SD = 0.07; %CV = 1.7. SINCE % CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. AS REVIEWED ON 12/21/2010, 12 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #243934 YIELDING A COMPLAINT RATE OF 0.009%. 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: 4.1, 4.2, LAB: 3.0. PREVIOUS STRIP LOT (234526) NEW STRIP LOT (243934). TESTING PERFORMED WITHIN 1/2 HOUR OF LAB DRAW. HER TARGET RANGE 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1