BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1532805 · Received October 29, 2009

    Report

    Report Number
    2027969-2009-00982
    Event Type
    Malfunction
    Date Received
    October 29, 2009
    Date of Event
    October 5, 2008
    Report Date
    October 29, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: STRIP CODE: 4X2YN, STRIP LOT: 080818. PER TECH SUPPORT REP, THE FIRST TWO TESTS WERE CONDUCTED OVER AN HOUR APART. STRIP CODE: MY55J, STRIP LOT: 213037. 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. NO FURTHER INVESTIGATION IS REQUIRED. SUMMARY: 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. METER WAS EXPECTED TO BE RETURNED BUT NOT RECEIVED. FURTHER TEST IS NOT REQUIRED AT THIS TIME. AS OF 10/13/2009, 4 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT # 213037 YIELDING A COMPLAINT RATE OF 0.008%. 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 10/29/2009, 22 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT# 080818 YIELDING A COMPLAINT RATE OF 0.006%. 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 IS REQUIRED AT THIS TIME AS NO PRODUCT DISCREPANCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" USING STRIP CODE: 4X2YN. USING STRIP CODE: MY55J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100267 080818

    Patients

    Seq Age Sex Outcome Treatment
    1 NI