BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3240893 · Received July 17, 2013

    Report

    Report Number
    2027969-2013-00580
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH REFERENCE RESULTS PROVIDED BY THE END-USER AT TIME COMPLAINT WAS FILED: DATE (B)(6) 2013, INRATIO RESULT 1.7; REFERENCE RESULT 6.3; MEAN 4.0; CONFIDENCE LIMITS 2.3 - 5.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WAS CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA WERE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON REPORTED LOT 304230 ON (B)(4) 2013 YIELDED THE FOLLOWING RESULTS: DONOR (B)(4): INRATIO 2.2, 2.1, 2.2; REFERENCE 1.97; BIAS THRESHOLD 1.47 - 2.47; %CV 2.66. DONOR (B)(4): INRATIO 2.9, 3.4, 3.1; REFERENCE 2.89; BIAS 1.89; BIAS THRESHOLD 1.89 - 3.89; %CV 8.03. ALL REPLICATES FOR EACH DONOR WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN (B)(4). PRECISION CRITERIA HAD BEEN MET. NO FURTHER INVESTIGATION REQUIRED. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIPS TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. AS REVIEWED ON (B)(4) 2013, (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #304230 YIELDING A COMPLAINT RATE OF (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 DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE (B)(6) 2003, INRATIO 1.7, LAB 6.3. THERAPEUTIC RANGE: UNKNOWN. TESTS OCCURRED WITHIN AN HOUR OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332003 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 304230

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| MEGACE| AMIODARONE| LEVOTHYROXINE| POTASSIUM SUPPLEMENT| FUROSEMIDE| ATORVASTATIN| PANTOPRAZOLE