BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 1569424 · Received December 17, 2009

    Report

    Report Number
    2027969-2009-01191
    Event Type
    Injury
    Date Received
    December 17, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 17, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: INRATIO: 2.3, REFERENCE: 5.6, MEAN: 3.95, CONFIDENCE LIMITS: 2.3-5.7. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED 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. TESTING WAS PERFORMED ON RETURNED METER AND STRIPS. METER FUNCTIONAL TEST DID NOT REVEAL METER DEFICIENCY. IT WAS REVEALED THAT PATIENT WAS GIVEN VITAMIN K AFTER RECEIVING LAB RESULT OF 5.6 INR. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF END-USER'S DISCREPANCY. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. AS OF 2009, FIVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 210381 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. 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 LOT 210831PA ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND 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: 2009, INRATIO: 2.3, LAB: 5.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 200457 210831PA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention