BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1532889 · Received October 30, 2009

    Report

    Report Number
    2027969-2009-00988
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    October 8, 2009
    Report Date
    October 30, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 3.5, REF: 2.5, MEAN: 3.00, CONFIDENCE LIMITS: 1.8-4.2. TIME OF TEST BETWEEN INRATIO AND LAB OCCURRED ON THE SAME DAY. HOWEVER, THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR THE COMPARISON TO BE VALID. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED THAT BOTH INRATIO AND LAB 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. APPLYING TWO DROPS OF SAMPLING DURING TESTING COULD CAUSE A HIGHER INR VALUE. METER AND STRIPS WERE NOT EXPECTED TO BE RETURNED. FURTHER TESTING IS NOR REQUIRED AT THIS TIME. AS OF 10/19/2009, TWELVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #213040 YIELDING A COMPLAINT RATE OF 0.003%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED TA 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) 2009, INRATIO: 3.5, LAB: 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100139 213040A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI