MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS OMNI LYSIS REAGENT; ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID

Catalog Number 06997538190

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Chemical Exposure (2570)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

The system's user manual notes that the system waste contains lysis reagent.Filling bleach or dna away" surface decontaminant into the liquid waste container can result in a chemical reaction producing cyanide.Do not pour bleach or dna away" surface decontaminant into the liquid waste container or any part of the fluid system.Within the warnings and precautions section of the package insert for the cobas¿ sars-cov-2 qualitative assay for use on the cobas¿ 6800/8800 systems, it states: do not allow cobas omni lysis reagent, which contains guanidine thiocyanate, to contact sodium hypochlorite (bleach) solution.This mixture can produce a highly toxic gas.Dispose of all materials that have come in contact with samples and reagents in accordance with country, state, and local regulations.The safety data sheet for the cobas¿ omni lysis reagent test has specific instructions on how to handle the hazards in section 4 first aid measures; if inhaled: move to fresh air.If unconscious, place in recovery position and seek medical advice.If symptoms persist, call a physician.Common device name (assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus) truncated due to character limitations.(b)(4).

Event Description

A us customer reported a lab operator inhaled fumes generated when mixing the c6800/8800 systems waste with waste bleach water from another system down the laboratory's sink drain.The operator stated that there was yellow/orange substance and smoke and as she leaned over to turn on the water to flush the sink she inhaled the smoke.The operator went to occupational health and the attending physician reported the technician had minor lung irritation.The operator was given an inhaler and steroid, and was sent her to work with no restrictions.The operator's current condition was noted as her chest is hurting, feeling heavy.The operator has asthma and went outside to breathe fresh air and is currently still working in the lab at this time.It was noted that the site is running the cobas sars-cov-2 test on the cobas 6800/8800 systems.

• Brand Name: COBAS OMNI LYSIS REAGENT
• Type of Device: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 11344102
• MDR Text Key: 232426303
• Report Number: 2243471-2021-00349
• Device Sequence Number: 1
• Product Code: MZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 06997538190
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention