MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT 3D COMBINATION; BACT/ALERT® 3D COMBINATION

Model Number 200291

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of obtaining delayed results due to an obstructed b side drawer not opening for the bact/alert® combo instrument (bta3d combination module left, ref.200291, serial (b)(4)).The customer called biomérieux customer support to address the issue of the inability to open the b side drawer.A biomérieux field service engineer (fse) was dispatched to the customer site but was unable to arrive until the next day.In the meantime, a patient bottle in the drawer alerted as positive.The customer was unable to access it.The patient did have a mate bottle, still showing ntd (negative to date).It was determined that a bottle in the bottom rack was preventing the ability to open the drawer.The customer removed the side panel before fse arrival and was able to push the obstructing bottle back into the cell, then open the drawer.The customer reported that there was a positive bottle alert at approximately 1500, (b)(6) 2020.It took until 0700 on (b)(6) 2020 for the customer to correct the drawer issue and access the positive bottle, leading to a delay in confirming the positive result.The positive bottle was on the instrument for approximately 16-17 hours.The patient died before the positive bottle result could be confirmed.The customer was unable to provide the patient time of death.The patient that died was an elderly patient admitted with sepsis and possible covid.The patient had four bottles drawn, and only the one bottle of the four became positive.The customer performed a pcr test (bc id) with a result of klebsiella pneumoniae.The customer confirmed that the patient death was not due to delayed results.The patient was already being treated with antibiotics for sepsis, and the blood culture results would not have changed their treatment.The delay in the blood culture result did not affect patient¿s treatment or outcome, and it did not result in any incorrect action.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of obtaining delayed results due to an obstructed b side drawer not opening for the bact/alert® combo instrument (bta3d combination module left, ref.200291, serial (b)(6).Back up data was requested from the customer to assist with determining if any error codes were present during the instrument issue.The customer was unwilling to provide backup data.The customer claimed that the issue was corrected by removing the side cover in order to access the bottle, however the investigation determined that removing the side cover does not allow access to the bottle in the rack.The instrument frame blocks access to bottles.It was determined that the user may have eventually opened the drawer enough to reach in and push the bottle back into the cell so the drawer could be fully opened.The previous three (3) preventive maintenance (pm) checklists from 2018, 2019, and 2020 were reviewed and there were no issues noted in any of the pms to indicate the drawers had any issues opening and closing.The root cause of this issue could not be determined, however it is likely that the issue was caused by the user not fully pushing the bottle into the cell and it caused an obstruction in the drawer when the user pulled the drawer open.No further investigation can be completed without a data backup from the customer.

• Brand Name: BACT/ALERT 3D COMBINATION
• Type of Device: BACT/ALERT® 3D COMBINATION
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11059505
• MDR Text Key: 247131691
• Report Number: 1950204-2020-00219
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026047573
• UDI-Public: 03573026047573
• Combination Product (y/n): N
• PMA/PMN Number: K903505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 200291
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1