BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1960860 · Received December 17, 2010

    Report

    Report Number
    2027969-2010-02208
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 13, 2010
    Report Date
    December 17, 2010
    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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 3.2; 2ND INR: 3.5; 3RD INR: 4.4; 4TH INR: 2.0; MEAN: 3.28; SD: 0.99; %CV: 30.22. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 1: 1ST INR: 2.4; 2ND INR: 2.4; 3RD INR: 2.6; MEAN: 2.47; SD: 0.12; %CV: 4.68. DONOR 2: 1ST INR: 2.3; 2ND INR: 2.4; 3RD INR: 2.4; MEAN: 2.37; SD: 0.06; %CV: 2.44. 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 12/16/2010, TWELVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #237411 YIELDING A COMPLAINT RATE OF 0.033%. 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR: 3.2, 3.5, 4.4, 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 237411

    Patients

    Seq Age Sex Outcome Treatment
    1 NI