BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGATTRACT DNA MINI M48 KIT

    MDR report key: 1614920 · Received February 22, 2010

    Report

    Report Number
    3004013603-2010-00001
    Event Type
    Other
    Date Received
    February 22, 2010
    Date of Event
    January 6, 2010
    Report Date
    February 22, 2010
    Manufacturer
    QIAGEN GMBH
    Product Code
    NTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BLEACH IS USED IN THIS LABORATORY. THE CUSTOMER INDICATED THAT BLEACH OR BLEACH-SOAKED TOWELS MAY HAVE BEEN IN THE BIN WITH THE M48 WASTE AND THAT THIS MAY HAVE BEEN THE CAUSE OF THE FUMES. THE CUSTOMER IS AWARE THAT THE MAGATTRACT M48 REAGENTS SHOULD NOT BE MIXED WITH BLEACH, SINCE THE REAGENTS CONTAIN GUANIDINE HYDROCHLORIDE/GUANIDINE THIOCYANATE. THE CURRENT MAGATTRACT DNA MINI M48 HANDBOOK (PACKAGE INSERT) INCLUDES THE FOLLOWING INFORMATION UNDER THE SAFETY INFORMATION. "CAUTION: DO NOT ADD BLEACH OR ACIDIC SOLUTIONS DIRECTLY TO THE SAMPLE-PREPARATION WASTE." BUFFERS MW1 AND MTL CONTAIN GUANIDINE HYDROCHLORIDE/ GUANIDINE THIOCYANATE, WHICH CAN FORM HIGHLY REACTIVE COMPOUNDS WHEN COMBINED WITH BLEACH.

    Description of Event or Problem · 1

    THREE (3) TECHNICIANS WERE CLEANING THE FORENSIC LABORATORY WHEN FUMES DEVELOPED. THE QIAGEN BIOROBOT M48 INSTRUMENT AND OTHER INSTRUMENTS ARE LOCATED IN THE LABORATORY, WHICH IS A GENERAL CHEMICAL PREPARATION AREA. FUMES WERE DETECTED AT THE WASTE BIN BY THE QIAGEN BIOROBOT M48 INSTRUMENT. FIRST EMPLOYEE FELT NAUSEOUS AND EXPERIENCED COUGHING. HER SYMPTOMS WENT AWAY WHEN SHE LEFT THE ROOM. SECOND EMPLOYEE FELT THROAT DISCOMFORT. THIRD EMPLOYEE DID NOT FEEL ANYTHING AT THE TIME BUT LATER EXPERIENCED RESPIRATORY DISTRESS. CONSEQUENTLY, THE FIRE DEPARTMENT WAS CALLED IN. THE THREE EMPLOYEES WERE TAKEN TO THE HOSPITAL, TAKEN THROUGH HAZMAT TREATMENTS, AND SPENT THE NIGHT IN THE HOSPITAL AS A PRECAUTION. THE FIRE DEPARTMENT USED A PHOTO-IONIZATION DETECTOR ("OFF-GAS READER") AND FOUND A READING OF 125 PPM WHERE THE M48 SAMPLE PLATES HAD BEEN DISCARDED. THIS VAPOR NUMBER ONLY TELLS WHERE THE VAPOUR IS COMING FROM, NOT WHAT THE VAPOR IS. THE FIRE DEPARTMENT WAS UNABLE TO DETERMINE THE SPECIFIC SOURCE OF THE SIGNAL. SUBSEQUENT TO THE HAZMAT TREATMENT AND HOSPITAL VISIT, THE EMPLOYEES ARE EXHIBITING NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGATTRACT DNA MINI M48 KIT SAMPLE PREPARATION KIT NTW QIAGEN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization