MAUDE Adverse Event Report: BIOMERIEUX, INC. BACT/ALERT® 3D INSTRUMENT

Model Number	200290
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of smoke being from emitted their bact/alert® 3d instrument.The customer stated smoke was observed coming from the upper part of the bact/alert® 3d instrument near the control panel.After the instrument was disconnected and taken out of service, a replacement bact/alert® 3d instrument was installed.There is no indication or report from the laboratory that the smoking instrument led to any adverse event related to user or patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation in response to a customer complaint of observed smoke from their bact/alert® 3d instrument (ref.(b)(4), serial (b)(6)).Investigational testing of the customer's instrument could not be performed; the bact/alert® 3d instrument had been shipped to a third party for destruction and replaced with another unit.Biomérieux confirmed the observed smoke occurred following an on-site service visit by a biomérieux field service engineer (fse).The fse confirmed that the insulation of the red (positive) agitation wire and the black (negative/ground) agitation wire, as part of the cable assemblies (b)(6) and (b)(6), was melted.Interviews with the fse and review of provided photographs determined the cables became pinched, due to wire misalignment, when the fse closed the electronics compartment of the bact/alert® 3d instrument.Internal testing at the manufacturing site confirmed when there was an electronic short in cable assembly (b)(6), the excessive current flow on the wires caused them to heat up and melt the insulation.There was no fire observed on the wires during the internal testing.The failure to generate a fire was expected based on the wires' insulation material.The wires are rated by underwriters laboratories as follows: ul1061, ul 1007, and ul1569 that meet the requirements of ul 758 (appliance wiring material standard) and are rated for the horizontal flame test as detailed in section 1090 of ul 1581 - reference standard for electrical wires, cables, and flexible cords.Based upon the provided photographs, interviews, and internal laboratory testing the most probable root cause for the observed smoke was misalignment of a cable following a service visit by a fse.Additional guidance regarding placement of the bact/alert® 3d instrument cable assemblies has been provided to all field service engineers.

• Brand Name: BACT/ALERT® 3D INSTRUMENT
• Common Device Name: BACT/ALERT® 3D INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042 ; 3145068201
• MDR Report Key: 9365872
• Report Number: 1950204-2019-00316
• Device Sequence Number: 13994941
• Product Code: MDB
• UDI-Device Identifier: 03573026047566
• UDI-Public: 03573026047566
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K903505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 200290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown