BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1853585 · Received September 29, 2010

    Report

    Report Number
    2027969-2010-01611
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 29, 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
    KS, 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; INRATIO: 5.8; LAB: 4.7. INRATIO: 5.8; LAB: 3.8. UPON DISCREPANCY RECEIVED ABOVE, A SMALL CORRELATION OF 5 PEOPLE WAS PERFORMED. RESULTS AS FOLLOWS: PT 1, DATE: (B)(6) 2010; INRATIO: 3.5; LAB: 3.3. PT 2, (B)(6) 2010; 2.6; 2.1. PT 3, (B)(6) 2010; 3.2; 2.5. PT 4, (B)(6) 2010; 3.8; 3.0. PT 5, NG; NG. CALLER DID NOT HAVE SPECIFICS ON EACH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 234586

    Patients

    Seq Age Sex Outcome Treatment
    1 NI