BEUDAMED
    FDA Adverse Event Other Summary report: N

    1415939-1999-00013

    MDR report key: 257240 · Received December 23, 1999

    Report

    Report Number
    1415939-1999-00013
    Event Type
    Other
    Date Received
    December 23, 1999
    Date of Event
    December 1, 1999
    Report Date
    December 20, 1999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 12/01/1999 THE ACCOUNT REPORTED A NEGATIVE HCV 2.0 EIA RESULT FOR A SAMPLE WHICH TESTED POSITIVE WITH THE ORTHO HCV ASSAY AT TWO DIFFERENT LABORATORIES. A NEGATIVE RESULT WAS ALSO OBTAINED AT THE LAB, WHICH USES HCV 2.0 EIA. NO REPORT OR INJURY.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HCV 2.0 EIA, LOT NUMBER 56833M200, EXPIRATION DATE| 05/27/2000.