BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1640409 · Received March 18, 2010

    Report

    Report Number
    2027969-2010-00312
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 17, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED SINCE TESTING TIME EXCEEDED THREE HOURS BETWEEN THE TWO READINGS. PER ISSUE COMPLAINT, SAMPLES WERE PERFORMED WITHIN 8 HOURS OF EACH OTHER. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. FUNCTIONAL TEST WAS PERFORMED ON RETURNED METER. TEST RESULTS INDICATED THAT PRODUCT DEFICIENCY WAS NOT ESTABLISHED WITH RETURNED METER. AS OF (B) (6) 2010, SEVEN DISCREPANT RESULT 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. 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: 3.9, LAB: 2.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 220376

    Patients

    Seq Age Sex Outcome Treatment
    1 NI