BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2142556 · Received June 20, 2011

    Report

    Report Number
    2027969-2011-01367
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED BECAUSE PATIENT WAS TAKING LOVENOX. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." RECENT TEST CONDUCTED ON LOT #243934 ON 06/03/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 46 = 3.5, 3.5, 3.5 INR; DONOR 47 = 2.7, 2.6, 2.7 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 46 (3.09 INR) AND DONOR 47 (2.65 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). ACTION THRESHOLD HAS BEEN REACHED. (B)(4). CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TESTS. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: INRATIO: 3.4, LAB: 2.6. PATIENT SELF TESTER WENT TO THE LAB 20 MINUTES AFTER TESTING WITH THE INRATIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1