BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1899798 · Received November 10, 2010

    Report

    Report Number
    2027969-2010-01928
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.8, 2ND INR: 2.5, MEAN: 2.15, SD: 0.49, %CV: 23.02. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. PREVIOUS INVESTIGATION ON STRIP LOT #234130 REVEALED THAT PRECISION CRITERIA WAS MET. PRECISION WAS CALCULATED FROM ACCURACY TEST AND %CV OF DONOR 1 WAS 2.93. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PT WAS USING THE SAME FINGERSTICK. IMPROPER SAMPLING TECHNIQUE COULD HAVE CONTRIBUTED TO INACCURATE INR TEST RESULTS. AS REVIEWED ON 11/10/2010, FORTY-SEVEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #234130, YIELDING A COMPLAINT RATE OF 0.042%. 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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION 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, INR: 1.8; 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 NI