BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESEARCH BREAST LYMPH NODE ASSAY

    MDR report key: 998834 · Received February 14, 2008

    Report

    Report Number
    3004582358-2008-00001
    Event Type
    Other
    Date Received
    February 14, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 14, 2008
    Manufacturer
    VERIDEX LLC
    Product Code
    OCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VACUUM PUMP AND QIAGAN QIAVAC-24 PLUS ARE NOT A DEVICE (GENERAL LAB EQUIPMENT). DEVICE DID NOT MALFUNCTION. USER SET-UP OF VACUUM AND PUMP MAY NOT BE CORRECT. NO MEDICAL INJURY OR TREATMENT. LABELING FOR DEVICE (WARNING AND PRECAUTION #16) STATES: ALL PERSONNEL SHOULD FOLLOW UNIVERSAL PRECAUTIONS AND USE LAB SAFETY EQUIPMENT (I.E. SAFETY GLASSES, LAB COAT, GLOVES). IF AVAILABLE, A FUME HOOD SHOULD BE USED FOR PREPARING SAMPLE PREPARATION KIT REAGENTS, AND A BIOSAFETY CABINET SHOULD BE USED FOR PREPARING/HANDLING BIOLOGICAL MATERIAL IF A HOOD IS NOT AVAILABLE, CONSIDER USING A FACE SHIELD DURING THE HOMOGENIZATION STEP.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ABOUT SPRAYS OF ETHANOL COMING OUT OF VACUUM PUMP. ISSUE IS SPORADIC. CUSTOMER EMPTIES THE MANIFOLD AFTER EACH RUN AND NEVERTHELESS EXPERIENCE THE ISSUE. CUSTOMER SAYS SPRAY IS BLUE COLORED AND SOMETIMES HOT. CUSTOMER DID NOT EXPERIENCE ANY INJURIES OR BURNS. NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESEARCH BREAST LYMPH NODE ASSAY GENESEARCH SAMPLE PREPARATION KIT OCB VERIDEX LLC NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1