BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2480920 · Received March 1, 2012

    Report

    Report Number
    2027969-2012-00254
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS ON ONE PATIENT. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 3.3, RE-TEST: 4.4. TIME BETWEEN TESTING: MINUTES. LATER IN THE AFTERNOON, MORE TESTS WERE PERFORMED. DATE: (B)(6) 2012, INRATIO: 2.8, RE-TEST: 2.6. TIME BETWEEN TEST: MINUTES. LAB INR= >9, >10.2. TWO DIFFERENT LABS TESTED THESE SAMPLES. DATE: (B)(6) 2012, INRATIO: 2.5, LAB: 8.4. DATE: (B)(6) 2012, INRATIO: 2.2, LAB: 6.7. TIME BETWEEN TESTING: UNKNOWN. NURSES USED VENOUS BLOOD ON INRATIO METER AS WELL AS FINGER STICKS. NURSE WAS NOT SURE WHICH TESTING METHOD WAS APPLIED OR WHICH INRATIO METER WAS USED. MULTIPLE DROPS ARE USED, AND IF TWO TESTS ARE PERFORMED BACK TO BACK, THE SAME FINGER STICK SITE IS USED FOR EACH TEST. REFERENCE MDR 202769-2012-00253 AND 00254 FOR OTHER TWO INRATIO METERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 272918

    Patients

    Seq Age Sex Outcome Treatment
    1