MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS INSTRUMENT - 410895

Model Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of obtaining a misidentification of eubacterium limosum identified as bilophila wadsworthia with the vitek ms system (reference 410895), in conjunction with the vitek® ms rp5700 acquisition computer (ref.411032u, serial number #(b)(4)).Investigation: the investigator reviewed previous complaint reports searching for other, similar, customer reports ¿ misidentification due to an organism not being included in the knowledge base and non-optimal spot preparation.No other similar complaints were recorded regarding bilophila wadsworthia instead of eubacterium limosum.Additionally, no capas or non-conformities were found to be linked to the customer¿s complaint.Fine tuning - according to vilink alert tool criteria, no fine tuning was needed during customer¿s tests.Spot preparation quality ¿ the calibrator and sample spot preparation were non optimal; the ¿all peaks¿ values were heterogeneous.Reprocessing customer data with vitek ms kb v3.2 allows to get two "no identification" results and two single choice to bilophila wadsworthia.The spectra which gave "no identification" results were empty, which means that the issue comes from the sample preparation, no mass was detected.The suspected misidentification to bilophila wadsworthia instead of eubacterium limosum was obtained with a low identification score (-0.26 and -0.30) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).The sample preparation was non optimal, the ¿all peak¿ value vary between 0 to 126.Kb review: eubacterium limosum is present in the vitek ms kb v3.2 root cause -non optimal spot preparation actions local customer service provided the customer with additional training materials to help improve their spot preparation technique.Further, they proposed the customer use vitek® pickme (ref 423551/ 423546) for both calibrator and sample preparation in order to improve the spot quality.

Event Description

A customer in (b)(6) notified biomérieux of obtaining a misidentification of eubacterium limosum identified as bilophila wadsworthia with the vitek ms system (reference 410895), in conjunction with the vitek® ms rp5700 acquisition computer (ref.411032u, serial number #(b)(4)).The reference method used to identify bilophila wadsworthia was not disclosed by the customer.No information has been provided regarding any potential patient impact of the misidentification.A biomérieux internal investigation was initiated.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 12281874
• MDR Text Key: 283091730
• Report Number: 9615754-2021-00219
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 08/05/2021

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: 410895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1