BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAD, GS HBSAG EIA

    MDR report key: 3521078 · Received December 11, 2013

    Report

    Report Number
    MW5033392
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Report Date
    December 6, 2013
    Manufacturer
    BIO-RAD
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS TESTED AS A FALSE POSITIVE FOR (B)(6). ANTIBODY TO (B)(6) SURFACE ANTIGEN (MOUSE MONOCLONAL) (B)(6) EIA 3.0; EIA SCREENING, BIORAD 1109 11/15/2006 SCREENING. THE LOT NUMBER AND THE EXPIRATION DATES OF THE KIT WERE: 109HCC-50, EXP DATE 02/28/2014. DATES OF USE: (B)(6) 2013, DIAGNOSIS OR REASON FOR USE: INFECTIOUS DISEASE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647330 BIORAD, GS HBSAG EIA BIORAD LOM BIO-RAD 109HCC-50

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other