BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1640406 · Received March 18, 2010

    Report

    Report Number
    2027969-2010-00317
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 17, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 FILED: DATE: (B) (6) 2010; INRATIO METER = 1.4 INR; REF = 3.0 INR; MEAN = 2.20; CONFIDENCE LIMITS = 1.4-3.1. 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. METER WAS RETURNED AND PASSED FUNCTIONAL TESTING. TEST RESULT INDICATED PRODUCT DEFICIENCY WAS NOT ESTABLISHED. CUSTOMER'S OBSERVATION WAS REVIEWED AND CONFIRMED IN METER MEMORY. PT'S CONDITION WAS NOT PROVIDED. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCY. AS OF (B) (6) 2010, 5 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT# 225433 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. TRENDING INFO ON SECOND LOT LISTED IN COMPLAINT. AS OF (B) (6) 2010, 6 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT# 223042 YIELDING A COMPLAINT RATE OF 0.004%. 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. 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 FOLLOWS:" DATE: (B) (6) 2010, INRATIO: 1.4, LAB: >3.0. PER CALLER, NURSES ARE OBSERVING MULTIPLE ERRORS AND HAD TWO PTS WITH LOWER THAN EXPECTED RESULTS. CUSTOMER STATED THAT THEY OBSERVED SIMILAR READINGS WITH TWO OTHER PTS LAST WEEK - LOW RESULTS SIMILAR TO THOSE LISTED ABOVE, BUT DID NOT PROVIDE ANY SPECIFICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 225433

    Patients

    Seq Age Sex Outcome Treatment
    1