BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1576745 · Received January 4, 2010

    Report

    Report Number
    2027969-2010-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    November 25, 2009
    Report Date
    January 4, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 3.2, REFERENCE: 9.0, MEAN: 6.10, CONFIDENCE LIMITS: UNABLE TO DETERMINE. INRATIO: 3.9, REFERENCE: 9.0, MEAN: 6.45, CONFIDENCE LIMITS: UNABLE TO DETERMINE. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ACCURACY CRITERIA WAS NOT MET. REPLICATION TESTING WITH RETURNED METER DID NOT REPRODUCE COMPLAINT. PT WAS ON DIALYSIS, HOWEVER, IT WAS NOT KNOWN IF SHE HAD IT DONE ON THE SAME DAY HER BLOOD WAS DRAWN. INRATIO TEST RESULTS MAY REFLECT INTERFERENCE FROM DIALYSIS. METER MEMORY RECORD WAS REVIEWED AND FAILED. THE OUTCOME OF THE COMPLAINT INVESTIGATION DOES NOT DEMONSTRATE PRODUCT DEFICIENCY. FURTHER INVESTIGATION IS NOT REQUIRED. TRENDING AND TRACKING WILL BE PERFORMED IN REVIEW OF STRIP LOT#220387. TOTAL NUMBER OF DISCREPANT COMPLAINTS FOR THIS STRIP LOT, INCLUDING THIS EVENT, IS ONE. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS ON RETURNED UNIT (B) (4): THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF LOT 220378 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2009, INRATIO: 3.2, 3.9, LAB: 9.0, 9.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220378

    Patients

    Seq Age Sex Outcome Treatment
    1 NI