BEUDAMED
    FDA Adverse Event Other Summary report: N

    GS HIV-1 WESTERN BLOT

    MDR report key: 1068860 · Received June 30, 2008

    Report

    Report Number
    3022521-2008-00003
    Event Type
    Other
    Date Received
    June 30, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MVW
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B) (6) WESTERN BLOT PACKAGE INSERT STATES ON PAGE 4, WARNINGS FOR USERS, #4 THE FOLLOWING "NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT. THEREFORE, ALL HUMAN BLOOD DERIVATIVES, REAGENTS AND HUMAN SPECIMENS SHOULD BE HANDLED AS IF CAPABLE OF TRANSMITTING INFECTIOUS DISEASE". BIO-RAD LABORATORIES IS FILING THIS REPORT SOLELY BASED ON THE STATEMENT IN THE (B) (6) WESTERN BLOT PACKAGE INSERT AND NOT BECAUSE OF ANY KNOWN DEFECT OF THE PRODUCT.

    Description of Event or Problem · 1

    BIO-RAD LABORATORIES REC'D A CALL FROM THE CENTER FOR DISEASE CONTROL IN (B) (6), REQUESTING INFO ON THE INACTIVATION PROCESS FOR (B) (6) WESTERN BLOT LOW POSITIVE CONTROL. THE CUSTOMER WAS INFORMED THAT THE CONTROL MATERIAL FOR THE (B) (6) WESTERN BLOT IS HEAT INACTIVATED FOR 30 MIN AT 56 DEGREES CELSIUS AND IS CERTIFIED TO BE NON-REACTIVE FOR (B) (6) AND (B) (6) ANTIBODIES, WHICH IS THE STANDARD PROCEDURE FOR INACTIVATION AND THE PROCESS HAS BEEN VALIDATED. THE CALLER STATED THAT WHILE DISCARDING AN OLD KIT OF (B) (6) WESTERN BLOT, A TECHNICIAN AT CDC WAS SPLASHED IN THE EYE WITH THE WESTERN BLOT LOW POSITIVE CONTROL. THE TECHNICIAN, AT THE TIME, WAS WEARING EYE PROTECTION, BUT IT DID NOT SEAL AROUND THE FACE AND THE LIQUID SPLASHED OVER THE RIM OF THE GLASSES. THE TECHNICIAN USED THE EYE WASH STATION TO FLUSH THE MATERIAL FROM THEIR EYES. AT THAT TIME, THE TECHNICIAN REQUESTED TO BE SEEN BY A PHYSICIAN AND WAS SUBSEQUENTLY TESTED FOR (B) (6). RESULTS OF THE TESTING ARE NOT KNOWN BY BIO-RAD. THE CUSTOMER WAS RELUCTANT TO GIVE ANY FURTHER INFO ABOUT FUTURE FOLLOW-UP FOR FEAR IT COULD COMPROMISE THE TECHNICIAN'S CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GS HIV-1 WESTERN BLOT HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 MVW BIO-RAD LABORATORIES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1