BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1849766 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01582
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, PT 1, INRATIO: >7.5, LAB: 5.2. DATE: (B)(6) 2010, PT 3, INRATIO: >7.5, RE-TEST: 3.2, LAB: 2.7. FOR PT # 1, LAB DRAW WAS 30 MINUTES AFTER METER TEST. FOR PT #3, LAB COMPARISON WAS DONE IMMEDIATELY AFTER METER TESTING. CUSTOMER STATED THEY WERE WIPING THE FIRS DROP OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1