BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1491116 · Received August 6, 2009

    Report

    Report Number
    2027969-2009-00627
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    July 7, 2009
    Report Date
    August 5, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6)2009. THE 6.2 AND 7.2 INR CAN'T BE FOUND ON DATA MEMORY FOR METER (B)(4). THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH VALUES ARE ABOVE THE 5.0 MEAN FOR ALL TESTS AND THE DIFFERENCE IS LESS THAN 2.2 FOR TEST 2. THESE RESULTS ARE CONSIDERED ACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. TESTING WAS PERFORMED ON THE RETURNED METER AND RETURNED STRIPS: IN-HOUSE ACCURACY TEST. TEST DATE: DONOR 4 ((B)(6)2009), DONOR 5 ((B)(6)2009). RETURNED METER (B)(4), IN-HOUSE METER (B)(4). RETURNED STRIP: (B)(4) (STRIP CODE: 7L1D2). COMPARATIVE SYS: SYSMEX 560, 2 THERAPEUTIC DONORS. RESULTS: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES BOTH SAMPLES FOR EACH LOT ARE WITHIN THE ALLOWABLE BIAS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER SECTION IS REQUIRED. NO STRIP DEFICIENCY WAS ESTABLISHED. RETURNED METER WAS TESTED WITH POWER SUPPLY AND TESTED WITH THERMOMETER SENSING TIP. IT MEASURED AN INCREASING TEMPERATURE FROM 23.50 - 36.85 DEGREES C, WHICH INDICATES A HEATER PLATE IS WORKING WITHIN THE STANDARD SPECIFICATION. PRODUCT DEFICIENCY NOT ESTABLISHED. NO FURTHER INVESTIGATION REQUIRED. AS OF 8/04/2009, 4 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT# 210832, YIELDING A COMPLAINT RATE OF 0.005%. 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0200431 210832

    Patients

    Seq Age Sex Outcome Treatment
    1 NI