MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT - 410895; VITEK® MS INSTRUMENT - 410895

Model Number 410895

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

On (b)(6) 2020, an industry customer in (b)(6) notified biomérieux of obtaining a misidentification of a staphylococcus species (not pathogenic) as a staphylococcus aureus in association with the vitek® ms instrument ¿ ref.410895; serial# (b)(4).The customer stated they obtained an identification to staphylococcus aureus species (coagulase positive, 99.9% confidence level).The strain was sent to another laboratory to perform a coagulase test that gave a negative result (not pathogenic species).As this was reported by a biomérieux industry customer, the misidentification did not impact any patient.

Manufacturer Narrative

A customer in canada notified biomérieux of obtaining an organism misidentification while using the vitek® ms instrument (ref.410895, serial number (b)(6)).The initial and retest both gave a single choice of steptococcus aureus ((b)(6) 2020 and (b)(6) 2020, respectively).However the sample was also coagulase test negative, which is not consistent with an s.Aureus identification.The actual identification is unknown as no reference method was used (i.E.Sequencing).Investigation.Fine tuning.The fine tuning status appeared good at the time of acquisition.Sample data analysis analysis of the customer¿s mzml data show that number of all peaks are homogeneous (between 82 and 93 peaks).Moreover, the misidentifications were obtained with a good identification score.Further investigation would be required to determine the cause of the misidentification.However, local customer service stated the customer could not submit the strain or a sequencing report and did not wish to proceed with the investigation.Consequently, the investigation has been finalized without any strain return and the cause of the issue was determine as unknown.A review of complaints starting from january 2016, showed no similar complaints linked to a misidentification as staphylococcus aureus with vitek ms knowledge base v3.2.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK® MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11096430
• MDR Text Key: 242822664
• Report Number: 9615754-2020-00196
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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: Other
• Device Model Number: 410895
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1