Bact Alert 3d Operator Manual
At a minimum, disposable gloves, eye protection, and a laboratory coat should be worn. ' the bact/alert 3d system is designed to limit the effects of leaks as the user manual states: 'each bottle cell within the bact/alert 3d incubation module is sealed to help contain and minimize effects of liquid spillage.
Bact Alert 3d System
Biomerieux Bact/alert 3d
A customer reported that a cell in their bact/alert instrument failed qc. While inspecting the cell, the customer found the loaded bottle had cracked and the contents had leaked into the cell. Error code 60 'cell failed qc' alerted the customer that the cell had malfunctioned. The bact/alert user manual instructs the user to identify the failed cell, inspect the cell for debris and remove or clean if necessary, and then to recalibrate the cell. The customer was not wearing gloves while performing the qc check and was required to fill out an incident report following the hospital/lab protocol. The safety precautions and procedures section in the bact/alert user manual contains general precautions that recommend: 'the following precautions should be observed during maintenance and repair, even in situations where a spill is neither observed no suspected. At a minimum, disposable gloves, eye protection, and a laboratory coat should be worn. ' the bact/alert 3d system is designed to limit the effects of leaks as the user manual states: 'each bottle cell within the bact/alert 3d incubation module is sealed to help contain and minimize effects of liquid spillage. ' the user manual also refers the customer to follow the clsi guideline m-29a 'protection of laboratory workers from instrument biohazards and infectious disease transmitted by blood, body fluids, and tissue. ' the customer is unsure whether the bottle was dropped or if the pneumatic tube system was used to transport this bottle in their facility. The customer reported the crack was on the bottom of the bottle. Although, the customer report no injury, they did report the healthcare worker who checked the failed qc cell south medical treatment, per their laboratory procedure, to preclude exposure to the bottle contents. The healthcare worker had tests for hcab, hbag and hivsc, and all results were negative. The customer is not willing to disclose any additional info about the healthcare worker's tests, and the customer is not able to disclose what microorganism the patient was being tested for because, the sample was received from another hospital and the info is protected by hipaa regulations. An investigation has been opened to examine the bottle crack. There have been no other bottle breaks for this lot. As there are no similar complaints with this lot, there is no indication that this issue will recur. This event is reportable to the fda as an adverse event because, the customer has to seek medical treatment to determine exposure to the inoculated bottle media. No report of medical injury has been recorded at this time.