BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1617335 · Received February 17, 2010

    Report

    Report Number
    2027969-2010-00178
    Event Type
    Injury
    Date Received
    February 17, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 15, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: LOT #221727. DATE: (B) (6) 2010, 1ST INR: 1.8, 2ND INR: 2.7, MEAN: 2.25, SD: 0.636, %CV: 28.28. SINCE %CV IS MORE THAN 20%, THE TEST FAILED THE CRITERIA FOR PRECISION. NO PRODUCT IS EXPECTED TO RETURN, RETAIN TESTING ON LOT #221727 WILL BE PERFORMED. RESULTS FOR RETAIN TESTING ON STRIP LOT# 221727 FROM A PREVIOUS CASE PERFORMED ON (B) (6) 2010 AS FOLLOWS: THERAPEUTIC DONOR TESTING YIELDED VALID INR RESULTS FOR LOT# 221727: 3.2 INR; 2.7 INR, MEAN: 2.93, SD: 0.251, %CV: 8.58; 2.9 INR. RESULTS FROM SAMPLE TESTING PASS CRITERIA FOR PRECISION TESTING, WITH A YIELDED %CV OF 8.58. PRODUCT DEFICIENCY NOT ESTABLISHED. CONCLUSION: DATA ANALYSIS OF CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED PRECISION CRITERIA WAS NOT MET. FOLLOW-UP COMPARISON DATA COULD NOT BE USED IN DATA ANALYSIS FOR TIMING BETWEEN INRATIO TEST AND REFERENCE TEST WAS GREATER THAN 3 HOURS AND DISCREPANCIES WERE LIKELY DUE TO CHANGES IN THE STATUS OF THE PT. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAIN STRIP DEFICIENCY WAS NOT ESTABLISHED. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF (B) (6) 2010, 11 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT# 221727 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. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DATE: (B) (6) 2010, INRATIO: 1.8; DATE: (B) (6) 2010, INRATIO: 2.7. PT'S COUMADIN DOSE WAS CHANGED (B) (6) 2010 FROM 5MG TO 7.5MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 221727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other