BEUDAMED
    FDA Adverse Event Summary report: N

    BIOPLEX 2200 HIV AG-AB CONTROL SET

    MDR report key: 6169746 · Received December 13, 2016

    Report

    Report Number
    1000135116-2016-00001
    Date Received
    December 13, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 9, 2016
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    MZF
    UDI-DI
    03610520506493
    PMA / PMN Number
    BK140111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED TO SEE IF BIO-RAD HAS MSDS FOR THE (B)(6) QC THAT ONE OF HIS TECHNICIANS ACCIDENTALLY SPLASHED IN THEIR EYE. INFORMED HIM THAT ALL THE MSDS CAN BE FOUND ON OUR WEBSITE SEARCHING THE PRODUCT NUMBER. HE WAS ABLE TO LOCATE THE MSDS SO THEY CAN DETERMINE WHETHER OR NOT SHE WILL REQUIRE MEDICAL ATTENTION. HE SAID SHE WASN'T IN ANY DISTRESS OR ANY PAIN. THEY NEEDED TO DECIDED WHETHER OR NOT MEDICAL ATTENTION IS GOING TO BE REQUIRED AS A SAFETY PRECAUTION. REQUESTED HE GIVE US A CALL BACK AND LET US KNOW IF HIS EMPLOYEE ENDS UP GOING FOR MEDICAL TREATMENT. HE UNDERSTOOD. BIO-RAS PROVIDED A CASE # FOR THIS ACCIDENT AND FOLLOWED UP WITH THE FOLLOWING QUESTIONS FROM WHICH CUSTOMERS REPLIES ON 12/01/2016 AS FOLLOWS. CAN YOU DESCRIBE HOW THE CUSTOMER SPLASHED HER EYE: SHE ACCIDENTALLY DROPPED ONE OF THE QC VIALS AND THE LIQUID SPLASHED UPWARD TOWARDS ONE OF HER EYES; WAS HE WEARING PROTECTIVE EYEWEAR: SHE WAS NOT WEARING ANY SORT OF PPE, JUST HER GLASSES BUT THE LIQUID STILL GOT UNDERNEATH; WHAT WAS HER IMMEDIATE ACTION/TREATMENT AFTER HIS EYE WAS SPLASHED WITH THE (B)(6)CONTROL MATERIAL: SHE SOUGHT CARE FROM ONE OF THE HOSPITAL NURSES; WAS THERE ANY MEDICAL INTERVENTION DUE TO THE SPLASH OR ANY OTHER MEDICAL INTERVENTION RELATED TO THIS INCIDENT: NO MEDICAL INTERVENTION WAS DEEMED NECESSARY AT THE TIME; WAS AN INTERNAL INCIDENT REPORT CREATED BY THE CUSTOMER: NO INCIDENT REPORT WAS FILED BY THE LAB BECAUSE THEY DIDN'T FEEL IT WAS NECESSARY DUE TO THE MINOR ACCIDENT. THE SDS OF THE BIOPLEX 2200 (B)(6)AG-AB CONTROL SET DESCRIBES THE FOLLOWING BIOLOGICAL INGREDIENT AS INACTIVATED (B)(6) VIRUS AND HUMAN SERUM. NEGATIVE CONTROL: IT CONTAINS NORMAL HUMAN SERUM MATRIX MADE FORM DEFIBRINATED PLASMA THAT IS NON-REACTIVE FOR (B)(6); ANTIGEN POSITIVE CONTROL: IT CONTAINS INACTIVATED (B)(6) THROUGH VERIFIED TO BE NON-INFECTIOUS; ANTIBODY POSITIVE CONTROL: IT WAS HEAT-TREATED TO INACTIVATE THE (B)(6) AND HUMAN SERA WERE TESTED AND FOUND NON-REACTIVE FOR (B)(6) SURFACE ANTIGEN AND ANTIBODIES TO (B)(6). SINCE NONE OF CONTROL MATERIALS SHOWN ABOVE CONTAINS INFECTIOUS AGENTS, THE RISK TO THE AFFECTED PERSON OF HAVING AN (B)(6) INFECTION IS MINIMUM.

    Description of Event or Problem · 1

    THE CHEMISTRY SUPERVISOR ACCIDENTLY DROPPED ONE OF THE BIOPLEX 2200 AG-AB QUALITY CONTROL (QC) VIALS AND THE LIQUID SPLASHED TOWARDS HER EYES. THE OPERATOR WAS NOT WEARING ANY SORT OF PERSONAL PROTECTIVE EQUIPMENT (PPE), HOWEVER SHE WAS WEARING GLASSES. SOME OF THE LIQUID FROM THE QC VIAL DID SPLASH INTO ONE OF HER EYES. THE CHEMISTRY SUPERVISOR IMMEDIATELY SOUGHT CARE FROM ONE OF THE HOSPITAL NURSES FOR THE SPLASHED LIQUID IN HER EYE. ACCORDING TO THE NURSE, NO MEDICAL INTERVENTION WAS NECESSARY AT THAT TIME, SO NO INCIDENT REPORT WAS FILED BY THE LAB BECAUSE THEY DID NOT FEEL IT WAS NECESSARY DUE TO THE MINOR ACCIDENT. BIO-RAD LABORATORIES IS REPORTING THIS ADVERSE EVENT TO ENSURE THAT THE SPLASH HAS NO LONG TERM DAMAGE TO THE AFFECTED PERSON BECAUSE OF THE EXPOSURE TO THE BIOLOGICAL MATERIALS IN THE BIOPLEX 2200 AG-AB QUALITY CONTROL (QC) VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819410 BIOPLEX 2200 HIV AG-AB CONTROL SET BIOPLEX 2200 HIV AG-AB KIT MZF BIO-RAD LABORATORIES, INC N/A 49449 03610520506493

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other