BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS AMPLIPREP INSTRUMENT

    MDR report key: 3327064 · Received September 5, 2013

    Report

    Report Number
    2243471-2013-00028
    Event Type
    Injury
    Date Received
    September 5, 2013
    Date of Event
    July 18, 2013
    Report Date
    August 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS LTD.
    Product Code
    JJH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PERFORMED ACCORDING TO SPECIFICATION. NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATIONS. THE COMPLAINT WAS FILED AS THE LABORATORY TECHNICIAN (B)(6) EXPERIENCED REACTIONS TO FUMES/SMELLS EMANATING FROM THE COBAS AMPLIPREP INSTRUMENT WHEN IT WAS IN USE. THE SYMPTOMS INCLUDED AN ITCHY SKIN RASH AND "ALLERGIC RESPONSES". THE TECHNICIAN IS SEEING AN ALLERGIST FOR SKIN TESTING. (B)(6) STATED THAT EVEN WHEN THE COBAS AMPLIPREP INSTRUMENT IS NOT RUNNING, SHE STILL EXPERIENCES ISSUES WITH RASH IN THAT LAB. THE COBAS AMPLIPREP INSTRUMENT AUTOMATES PREPARATION OF SAMPLES FOR QUANTITATIVE OR QUALITATIVE NUCLEIC ACID TESTING USING PCR TECHNOLOGY. THE COBAS AMPLIPREP INSTRUMENT IS TO BE USED BY LABORATORY PROFESSIONALS TRAINED IN LABORATORY TECHNIQUES AND BY INSTRUCTION ON THE USE OF THE INSTRUMENT. EVALUATION OF THE COBAS AMPLIPREP INSTRUMENT ITSELF WAS NOT PERFORMED; RATHER, A REVIEW OF THE APPLICABLE MATERIAL SAFETY DATA SHEETS FOR THE PRODUCTS USED ON THE COBAS AMPLIPREP INSTRUMENT AS WELL AS THE SPECIFIC PRODUCT LABELING AND INSTRUMENT MANUAL WAS PERFORMED. THE REVIEW OF THE MSDS DOCUMENTS INDICATE THAT SOME REAGENTS USED ON THE COBAS AMPLIPREP INSTRUMENT COULD CAUSE IRRITATION TO THE RESPIRATORY TRACT AND TO THE SKIN IF EXPOSED; THE APPROPRIATE FIRST AID AND ENGINEERING MEASURES ARE ALSO PROVIDED. THE SPECIFIC PRODUCT LABELING NOTES THE SUFFICIENT WARNING AND PRECAUTIONS FOR HANDLING THE REAGENTS. THE INSTRUMENT MANUAL INDICATES THAT ODORS CAN BE MINIMIZED IF THE USED CONSUMABLES, CONTAINING THE WASTE, ARE REMOVED IMMEDIATELY AFTER THE RUN IS COMPLETED AND PLACED IN A BIOHAZARD BAG AND STORED IN A WELL VENTILATED AREA. AS ASSESSMENT FROM THE RMS MEDICAL AND SCIENTIFIC AFFAIRS INDICATED "IT DOES NOT APPEAR THAT THE CAP/CTM REAGENTS WOULD CAUSE THE SYMPTOMS ALLEGED IN THESE CASES. THE ONLY COMPONENT WHICH HAS RESPIRATORY SYMPTOMS, GLYCEROL, WOULD NEED TO BE PRESENT IN AEROSOLIZED QUANTITIES GREATER THAN WHAT IS PRESENT IN THE TESTS." (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN (B)(6), HAS COMPLAINED OF AN "ITCHY" SKIN RASH AND ALLERGIC RESPONSES ALLEGEDLY FROM FUMES/SMELLS/ODORS EMANATING FROM THE COBAS AMPLIPREP INSTRUMENT, WHEN IN USE. THE TECHNICIAN IS SEEING AN ALLERGIST FOR SKIN TESTING. (B)(6) STATED THAT EVEN WHEN THE COBAS AMPLIPREP INSTRUMENT IS NOT RUNNING, SHE STILL EXPERIENCES ISSUES WITH RASH IN THAT LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440644 COBAS AMPLIPREP INSTRUMENT CLINICAL SAMPLE CONCENTRATOR; CFR 862.2310 JJH ROCHE DIAGNOSTICS LTD. 394217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention