BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1888123 · Received October 26, 2010

    Report

    Report Number
    2027969-2010-01806
    Event Type
    Other
    Date Received
    October 26, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO INRATIO METERS WERE REPORTED. INRATIO METER: PART #100137, (B)(4), 510(K) 0219253. INRATIO2 METER: PART #200457, (B)(4), 510(K) 072727. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 2.1. DATE: (B)(6) 2010, INRATIO: 1.8. DATE: (B)(6) 2010, INRATIO: 1.3. DATE: (B)(6) 2010, INRATIO: 1.2. DATE: (B)(6) 2010, INRATIO: 1.5. DATE: (B)(6) 2010, INRATIO: 1.5. DATE: (B)(6) 2010, INRATIO: 1.4. DATE: (B)(6) 2010, LAB: 6.0. DR HAD BEEN ADJUSTING DOSAGE OF COUMADIN FOR SEVERAL WEEKS TO RAISE INR WITHOUT SUCCESS. PT WENT TO HOSP THAT WEEKEND ((B)(6) 2010) AND HAD INR AROUND 6.0 IN HOSP. GIVEN VITAMIN K AND BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234591

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O