BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1942192 · Received December 21, 2010

    Report

    Report Number
    2027969-2010-02215
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAS HYPOCOAGULOPATHY. PT CURRENT HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2010, INRATIO: 3.6, REFERENCE: 2.5, MEAN: 3.05, CONFIDENCE LIMITS: 1.8 - 4.2. DATE: (B)(6) 2010, 3.8, 2.5, 3.15, 1.9 - 4.6. 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 PROVED BY END-USER LOT: DATE: (B)(6) 2010, 1ST INR: 3.6, 2ND INR: 3.8, MEAN: 3.7, SD: 0.14, %CV: 3.82. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. STRIP LOT INFO IS NOT IN DATA YET. THERE ARE A TOTAL OF 26 COMPLAINTS IN THE SYS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING; CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 3.6, LAB: - (LOT #234526). DATE: (B)(6) 2010, 3.8, 2.5 (LOT #243934). LAB DRAW WITHIN ONE HOUR. PT AND PHYSICIAN PREFER A HIGHER READING IN THE THERAPEUTIC RANGE.

    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