BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1628423 · Received March 2, 2010

    Report

    Report Number
    2027969-2010-00264
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DATA ANALYSIS WAS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH REFERENCE RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B) (6) 2010, INRATIO: 5.5 INR, REFERENCE: 4.2, MEAN: 4.85, CONFIDENCE LIMITS: 2.6-6.9. (B) (6) 2010, 3.8 INR, 4.2 INR, 4.00, 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. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B) (6) 2010, 1ST INR = 5.5, 2ND INR = 3.8, MEAN = 4.65, SD= 1.20, %CV = 25.85. SINCE 25.85% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION ON STRIP LOTS 220376 AND 223042 FROM FORMER COMPLAINT INVESTIGATIONS ON THESE LOTS MEET PRECISION CRITERIA. INVESTIGATION RESULTS: RETAINS FROM LOT # 220376 WERE TESTED USING THERAPEUTIC DONORS AND IN-HOUSE METERS. RETURN METER AND STRIPS FROM THE FORMER COMPLAINT WERE ALSO USED FOR TESTING. RESULTS ARE AS FOLLOWS: SEE SCANNED TABLE. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 220376, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 2.84% AND 3.18%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED. RETAINS FROM LOT # 223042 WERE TESTED USING THERAPEUTIC DONORS AND IN-HOUSE METERS. (B) (4) FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 223042, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 2.84% AND 4.17%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED. SUMMARY: 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. DATA ANALYSIS OF CV% CALCULATION FROM INRATIO TEST DATA REVEALED PRECISION CRITERIA WAS NOT MET. NO PRODUCT IS EXPECTED TO BE RETURNED. RECENT PRECISION TEST RECORDS INDICATED PRODUCT DEFICIENCY WAS NOT ESTABLISHED IN RETAIN STRIP LOT #223042 AND 220376. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 03/01/2010, 4 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT # 223042 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. AS OF 03/01/2010, 6 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT # 220376 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. 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 REPORTED HIGHER THAN EXPECTED RESULTS AND IMPRECISION WITH 1 PT, 1 STRIP LOT INITIAL RESULT=5.5, REPEAT=3.8, 2ND STRIP LOT = 4.2. CALLER STATED THAT HISTORICAL READINGS WERE 2.0-2.5. PER CUSTOMER, NEXT DAY LAB TEST PERFORMED AND WAS CLOSER TO HISTORICAL READINGS. NO RESULTS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220376

    Patients

    Seq Age Sex Outcome Treatment
    1