BEUDAMED
    FDA Adverse Event Summary report: N

    INRATIO

    MDR report key: 2027468 · Received February 11, 2011

    Report

    Report Number
    2027969-2011-00480
    Date Received
    February 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY CUSTOMER. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 4.1 INR, REFERENCE: 3.0 INR, MEAN: 3.55, CONFIDENCE LIMITS: (2.0 - 5.0). THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM 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. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. STRIP L/N: 241836 MET ACCURACY CRITERIA. NO DEFICIENCY FOUND ON RETURNED UNIT. INR REPORTED IS REGISTERED ON UNIT'S MEMORY. INVESTIGATION DETAILS: UNIT UNDER INVESTIGATION WAS RECEIVED ON 3/3/2011. THE RETURNED UNIT'S MEMORY HAS BEEN DOWNLOADED AND REVIEWED. INR REPORTED IS REGISTERED ON UNIT'S MEMORY. STRIP INVESTIGATION WAS PERFORMED ON LOT 241836. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 241836 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. METER INVESTIGATION (INSPECTION): UNIT WAS THEN TESTED WITH THERMOMETER SENSING TEST DURING WARMING UP TO DETERMINE IF UNIT'S HEATER PLATE IS WITHIN THE ACCEPTABLE TEMPERATURE RANGE (36.00 - 38.00 DEGREES CELSIUS). PERFORMED THERMOMETER SENSING TEST ON UNIT AND BOTH THERMISTOR ARE MEASURED AS FOLLOWS: THERMISTOR # 1 = 36.39 DEGREES CELSIUS, THERMISTOR # 2 = 36.49 DEGREES CELSIUS. VISUAL INSPECTION REVEALED SLIGHT CONTAMINATION ON HEATER PLATE, BUT IT HAS NOT AFFECTED THE PERFORMANCE OF TEMPERATURE CONTROL CIRCUITRY. 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. RETURNED METER WITH RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (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 DR'S POINT OF CARE. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO INR: 4.1, DR'S POC INR: 3.0. TARGET INR RANGE IS 2.5 - 3.5. TESTS WERE DONE SIDE BY SIDE WITH TWO FINGER STICKS.

    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