BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2072970 · Received April 22, 2011

    Report

    Report Number
    2027969-2011-00900
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2011; INRATIO: 6.7, 7.5; LAB: 3.7, 3.9. CUSTOMER WAS USING INRATIO1 AND INRATIO2 METERS, BUT IS NOT SURE WHICH RESULT CAME FROM WHICH METER; INR = 6.7 AND 7.5. VENIPUNCTURE PERFORMED AT THE SAME TIME HAD INR = 3.7. PT WENT IMMEDIATELY TO THE HOSPITAL AND THEIR LAB DRAW = 3.9. PT DISPOSITION UNK. HCT = 41%. PT TAKES SYNTHROID. PT'S RESULTS WERE PART OF CUSTOMER'S 5-SAMPLE CORRELATION (METER-TO-METER) YESTERDAY. NOT AN ESTABLISHED PT, NO PREVIOUS RESULTS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232232

    Patients

    Seq Age Sex Outcome Treatment
    1