BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1598201 · Received January 29, 2010

    Report

    Report Number
    2027969-2010-00118
    Event Type
    Injury
    Date Received
    January 29, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 29, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    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) 10; INRATIO: 4.4; REFERENCE: 2.1; MEAN: 3.25; CONFIDENCE-LIMITS: 1.9-4.6. A 3.5 HOURS IS THE TIME LAPSE BETWEEN TWO READINGS. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. 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. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: NG; INRATIO: 4.9; REFERENCE: 3.02; MEAN: 3.96; CONFIDENCE-LIMITS: 2.3-5.7. 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. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT #221726 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER INVESTIGATION WILL BE PURSUED. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THERE IS NO INFO WHY THE PT IS EXPERIENCING BLACK-OUTS. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCY. AS OF (B) (6) 2010, FOUR DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT# 221726 YIELDING A COMPLAINT RATE OF 0.002%. 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. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010; INRATIO: 4.4; LAB: 2.1. DATE: (B) (6) 2010; INRATIO: 4.9; LAB: 3.02. PT BLACKED OUT IN THE SHOWER. WENT TO THE HOSP AND HAD HIS INR TESTED ABOUT 3 1/2 HOURS LATER. HAD BLACKED OUT IN THE PAST WHEN HIS INR IS TOO LOW. HOSPITAL WASN'T SURE IF THE REASON HE PASSED OUT IS RELATED TO HIS INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 221726

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization