BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1903061 · Received November 12, 2010

    Report

    Report Number
    2027969-2010-01946
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 12, 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
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 7.5; 2ND INR: 3.6; MEAN: 5.55; SD: 2.76; %CV: 49.69. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. PREVIOUS INVESTIGATION OF STRIP LOT 234527 REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. PRECISION WAS CALCULATED FROM ACCURACY TEST. %CV OF DONOR 1 = 2.79, WHICH IS LESS THAN 16%. FOLLOW UP WITH THE CUSTOMER REVEALED THAT PATIENT'S HIGH INRATIO INR VALUES WERE CONFIRMED BY THE LAB TEST. NO FURTHER INVESTIGATION REQUIRED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), 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 (PATIENT'S DAUGHTER) ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR: >7.5, 3.6. DATE: (B)(6) 2010; INRATIO: >7.5 (X3). FOLLOW UP WITH PATIENT'S DAUGHTER REVEALED THAT LAB INR VALUE WAS VERY HIGH AS WELL, BUT NO SPECIFIC VALUE WAS GIVEN. THE READINGS ON THE METER WAS CONFIRMED BY THE LAB TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234527

    Patients

    Seq Age Sex Outcome Treatment
    1 NI