BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1854650 · Received September 30, 2010

    Report

    Report Number
    2027969-2010-01617
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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:" ELEVEN DAYS AGO: 2.9 ON METER; TEN DAYS AGO: 2.9 ON METER; NINE DAYS AGO: WENT TO HOSPITAL AND VENIPUNCTURE IN HOSPITAL LAB WAS 3.7. PUT ON HEPARIN. EIGHT DAYS AGO: 3.9 IN LAB TEST. PT CALLED TO ASK ABOUT DISCREPANT RESULTS ON HER METER. SHE HAS BEEN BLEEDING FROM HER UTERUS FOR 3 MONTHS AND JUST HAD AN EMERGENCY HYSTERECTOMY. DISCREPANCY OCCURRED PRIOR TO HOSPITALIZATION. CUSTOMER NOT SURE OF EXACT DATES - MAY HAVE TESTED WITH METER ON THE SAME DAY AS HOSPITALIZATION OR DAY BEFORE. THOUGHT SHE WAS HOSPITALIZED SATURDAY ((B)(6) 2010). SHE HAD BEEN VERY ANEMIC. HCT TODAY WAS 25.8; MAY HAVE BEEN LOWER AS PT HAD BLOOD TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other