BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1640304 · Received March 16, 2010

    Report

    Report Number
    2027969-2010-00309
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 16, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILLED: DATE: (B) (6) 2010. INRATIO METER = > 7.5 INR; 7.5 INR IS UTILIZED FOR THE PURPOSE OF COMPARISON TEST REFERENCE = 1.8 INR. MEAN = 4.65 CONFIDENCE LIMITS = 2.6 - 6.9. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. PER ISSUE, LAB DRAW IS OBTAINED WITHIN 15 MINUTES, BUT GREATER THAN 4 HOURS LAPSE BETWEEN TWO READINGS. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. INVESTIGATION WAS PERFORMED FOR A PREVIOUS COMPLAINT ON THE SAME LOT. THERAPEUTIC DONORS WERE TESTED USING RETAINED STRIPS AND IN-HOUSE AND RETURNED METER (FROM PREVIOUS COMPLAINT). 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 LOT 222167 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ACCURACY CRITERIA HAS NOT MET. INCORRECT SAMPLE VOLUME WAS APPLIED IN TEST. PATIENT'S CONDITION OF ACUTE RENAL FAILURE MAY AFFECT INR TEST RESULT. AS OF (B) (6) 2010, 4 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #222167 YIELDING A COMPLAINT RATE OF 0.001%. 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 ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOW:" DATE: (B) (6) 2010, INRATIO2: >7.5, LAB: 1.8. LAB DRAW WAS WITHIN 15 MINUTES BUT >4 HOURS FOR RESULTS TO BE RUN. NURSE IS USING 2ND DROP OF BLOOD TO TEST. SHE WAS INSTRUCTED TO USE 1ST DROP OF BLOOD, AND A DIFFERENT FINGER FOR REPEAT. PATIENT DOES NOT HAVE CANCER OR ANEMIA. NOT ON ANTIBIOTICS. PATIENT IS IN ACUTE RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222167

    Patients

    Seq Age Sex Outcome Treatment
    1