BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2076143 · Received March 31, 2011

    Report

    Report Number
    2027969-2011-00662
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END USER: 1ST INR: 6.4, 2ND INR: 4.6, MEAN: 5.50, SD: 1.27, %CV: 23.14. GREATER THAN 7.5 INR RESULTS WERE EXCLUDED FROM COMPARISON TEST SINCE THEY ARE NOT VALID TEST RESULTS. GENERALLY, INR RESULTS EXCEEDING 5.0 HAVE REDUCED TRUENESS, PRECISION AND LINEARITY BOTH IN POINT-OF-CARE AND LABORATORY BASED PT TESTING. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON 03/16/2011 REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. INVESTIGATION RESULTS FOR STRIP LOT #241836: DONOR 1: 1ST INR: 2.7, 2ND INR: 2.8, 3RD INR: 2.8, MEAN 2.77, SD: 0.06, %CV: 2.09. DONOR 2: 1ST INR: 3.1, 2ND INR: 3.1, 3RD INR: 3.1, MEAN: 3.10, SD: 0.00, %CV: 0.00. SINCE %CV FOR BOTH DONORS ARE LESS THAN 16%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: GREATER THAN 7.5 (2X). INRATIO: 6.4. INRATIO: 4.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI