BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1601092 · Received January 27, 2010

    Report

    Report Number
    2027969-2010-00104
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 27, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 2.4, 2ND INR: 1.8, MEAN: 2.10, SD: 0.42, %CV: 20.20. DATA ANALYSIS ON CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED RESULTS FROM PATIENT'S INRATIO AND DOCTOR'S OFFICE INRATIO DID NOT MEET PRECISION CRITERIA. PRODUCTS IN COMPLAINT WERE NOT EXPECTED TO BE RETURNED. PRECISION TEST RECORDS FROM A PREVIOUS CASE WAS REVIEWED AND PRECISION CRITERIA WAS MET. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S DISCREPANT RESULT. PRECISION TEST RESULTS FROM A PREVIOUS CASE: DONOR 1: IN-HOUSE: 2.6, IN-HOUSE: 2.8, IN-HOUSE: 2.4, MEAN: 2.60, SD: 0.20, %CV: 7.69; DONOR 2: IN-HOUSE: 2.2, IN-HOUSE: 2.2, IN-HOUSE: 2.2, MEAN: 2.20, SD: 0.00, %CV: 0.00. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 220392, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 7.69% AND 0%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULTS WERE ESTABLISHED ON IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. AS OF 01/20/2010, TEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220392 YIELDING A COMPLAINT RATE OF 0.003%. 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 IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6)2010, INRATIO: 2.4, 1.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 220392

    Patients

    Seq Age Sex Outcome Treatment
    1 NI