BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1963307 · Received January 10, 2011

    Report

    Report Number
    2027969-2011-00057
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE COMPARISON TEST WAS NOT PERFORMED BECAUSE NO CORRESPONDING REFERENCE OR REPEATED INRATIO VALUE WAS PROVIDED BY THE CUSTOMER. REPORTED QC ERRORS COULD HAVE BEEN CAUSED BY STRIP EXPOSURE TO ADVERSE ENVIRONMENTAL CONDITIONS. IN ADDITION, THESE ERRORS COULD HAVE OCCURRED DUE TO SAMPLING OR TECHNIQUE PROBLEMS. THERE IS NO INFO IN THE COMPLAINT TO INDICATE STRIP EXPOSURE. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF CORRECTIVE ACTION IS WARRANTED. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT ACCURACY CRITERIA WAS MET. PER GENERAL DESCRIPTION OF COMPLAINT, PT WAS TAKING PARADAXA. PT'S CURRENT MEDICATION MAY HAVE AFFECTED COAGULATION TESTING AND LED TO THE UNEXPECTED INRATIO RESULTS AND REPORTED TEST ERRORS. AS OF (B)(6) 2011, ONE HUNDRED AND ONE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.031%. 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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT #233708: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT #233708 ARE WITHIN THE ALLOWABLE BIAS (+ OR -1.0). NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 4.3. PT HAD GUM BLEEDING ON (B)(6) 2010. DOCTOR INSTRUCTED HIM TO CUT PRADAXA FROM 300 MG TO 150 MG AND HIS BLEEDING STOPPED. PT TESTED AGAIN ON (B)(6) 2010 AND GOT QC2H ERRORS 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R