MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS MYCOB/NOCARDIA KIT - 415659

Model Number VITEK® MS MYCOBACTERIUM/NOCARDIA KIT

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Product intended use: the vitek® ms mycobacterium/ nocardia kit provides the reagents and consumables needed to process samples by protein extraction and inactivation for mycobacterium and nocardia identification using the vitek® ms system.Description of the issue: a customer from the united states reported that a bead tube from the vitek ms mycobacterium / nocardia kit (ref.415659 ¿ lot 1008403350) burst during the inactivation process.The customer reported that when performing step 3 of the inactivation process (disruption of the cells), the bead tube (tube with glass bead) used with the customer bead disruptor burst.The test was performed using biosafety level 3 practices as indicated the instruction for use.The bead disruptor instrument had an enclosure and was located inside a biological safety cabinet.Laboratory technicians wore personal protective equipment (ppe).Therefore, there was no laboratory technician exposure.

Manufacturer Narrative

A customer in the u.S.A.Notified biomérieux that a bead tube from the vitek® ms mycobacterium / nocardia kit (ref.(b)(4) ¿ lot 1008403350) burst during the inactivation process.The bead disruptor instrument was located inside biological safety cabinet and there is a specific enclosure for it.Staff wore personal protective equipment.Customer used bead ruptor elite from omni international.Investigation: the investigator reviewed the complaints database back to november 2017, to identify any previous reports similar to this customer¿s issue.No similar complaint has been recorded linked to a breakage of beads tubes.In addition, no complaint has been recorded against the batch number (batch # 1008403350).No capas nor non-conformities were identified that could be linked with the customer¿s complaint.Next, the investigator looked at the manufacturing process of vitek ms mycob/nocardia kit batch # 1008403350: - beads are a catalog reference : qiagen powerbead tubes, glass 0.5 mm cat.No./ id: 13116-50.These are not controlled internally at reception or during the packaging process.This reference of beads is used only for the vitek ms mycob/nocardia kit (no other reference impacted).- manufacturing files verification is not performed for the impacted batch (beads are catalog reference from qiagen, introduced in our production only at the packaging step).- the internal sample for batch 1008403350 was visually controlled (100 tubes) and had no broken tubes.After investigation with r&d department, - this issue was never observed internally - no specific criteria were defined during the development related to a maximal speed value during step 3 of the deactivation protocol - equipment used by r&d were vortex genie 2 bmx p/n 280174 (max speed 2700 rpm) or biospec mini-beadbeater-1 model# c321001 (max speed 4800 oscillations/min).After investigation with our supplier qiagen, - no specification sheets for the tubes could be provided - no specific criteria were defined for this product (speed value, freezing, force withstand) but they specified that beads are ¿compatible with all bead beating instruments¿ - this kind of tubes used with power lyzer homogenizer device were described in qiagen protocols.- power lyzer homogenizer device seems very close to the customer's equipment bead ruptor elite from omni international according to this information, the bead tubes should be compatible with the device used by the customer.Product documentation: package insert 20894c - equipment specification: o vortex-type mixer with adaptor or bead beater-type homogenizer o vortex-type mixer (maximum speed).- instructions for use: o all manipulation of mycobacterium must be performed using biosafety level 3 practices before the inactivation of the sample.- step 3 mentioned by the customer: o use a vortex-type mixer with adaptor (at maximum speed) to disrupt the cells for 15 minutes, or a bead beater-type homogenizer for 5 minutes.The protocol is clearly described and biosafety recommendations are mentioned.2/ sds us version a at mycobacteria / nocardia protocol step 3, only ethanol (r1) is used.The physical and chemical hazards were clearly identified in the safety data sheet.3/ vitek ms workflow user manual 4501-2233-f (see document attached): the biosafety recommendations are stated in case of mycobacterium and nocardia preparation.The biosafety recommendations are stated in vitek ms documentation.The issue was punctual.The reference (b)(4) is the only reference impacted.No action is to be taken.Root cause: cause not established.

• Brand Name: VITEK MS MYCOB/NOCARDIA KIT - 415659
• Type of Device: VITEK MS MYCOB/NOCARDIA KIT - 415659
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 12139440
• MDR Text Key: 281651402
• Report Number: 9615754-2021-00182
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026436971
• UDI-Public: 03573026436971
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• 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: 09/17/2021

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 Expiration Date: 10/30/2021
• Device Model Number: VITEK® MS MYCOBACTERIUM/NOCARDIA KIT
• Device Catalogue Number: 415659
• Device Lot Number: 1008403350
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1