BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS® HPV

    MDR report key: 20762087 · Received November 22, 2024

    Report

    Report Number
    2243471-2024-03401
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    MAQ
    UDI-DI
    00875197006889
    PMA / PMN Number
    P190028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 5800 WAS (B)(6). IT WAS INDICATED THAT THE APPROXIMATE SIZE OF THE LABORATORY ROOM IS 10 SQUARE METERS. ACCORDING TO THE OPERATOR, THERE IS NO VENTILATION IN THE ROOM AND NO AIR EXCHANGE. AFTER THE INCIDENT, A VENTILATION SYSTEM WAS INSTALLED IN THE LABORATORY. HOWEVER, THE ENGINEER WHO INSPECTED THE ANALYZER AND THE ROOM, CONCLUDED THAT THIS VENTILATION WAS INSUFFICIENT. PER THE SAFETY DATA SHEETS OF THE COBAS HPV ASSAY AS WELL AS THE USER ASSISTANCE OF THE COBAS 5800 INSTRUMENT, THE NEED FOR SUFFICIENT VENTILATION (AIR EXCHANGE) IS DESCRIBED; "PROVIDE SUFFICIENT AIR EXCHANGE AND/OR EXHAUST IN WORK ROOMS." THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE HAS BEEN IDENTIFIED TO BE OPERATING IN A SMALL ROOM WITHOUT SUFFICIENT AIR EXCHANGE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THAT DURING THE USE OF THE COBAS 5800 INSTRUMENT EXPERIENCED A CHEMICAL BURN TO THE UPPER RESPIRATORY TRACT. IT WAS ALLEGED TO HAVE OCCURRED DURING AN HPV RUN WHERE A SHARP UNPLEASANT ODOR EMANATED FROM THE DEVICE. THE OPERATOR ALLEGEDLY SOUGHT MEDICAL SUPPORT AND WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH A CHEMICAL BURN OF THE UPPER RESPIRATORY TRACT. IT IS UNKNOWN WHAT KIND OF MEDICAL TREATMENT WAS PROVIDED. ALLEGEDLY, BEFORE THE INCIDENT THE OPERATOR HAD NO HEALTH PROBLEMS. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE, NO ADDITIONAL INFORMATION ON THE OPERATOR'S STATUS COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799056 COBAS® HPV KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG ASKU 00875197006889

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention