BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1849775 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01573
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH METERS COMPARED TO LAB. PATIENT #8. DATE: (B)(6) 2010. LJ INRATIO METER: LOT #232170 - 1.4; LOT #236690 - 1.7. LS INRATIO METER: LOT #232170 - 1.4; LOT #236690 - 1.7. LAB: 1.63. DS AND LJ ARE THE INITIALS OF THE NURSES USING TWO DIFFERENT METERS. THESE WERE THE ONLY IDENTIFIERS THE CUSTOMER COULD PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHOMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232170

    Patients

    Seq Age Sex Outcome Treatment
    1