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

Model Number	410895
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mold infections.Description of issue: a customer in the united states notified biomérieux of a suspected organism misidentification as brucella species in association with the vitek ms instrument (ref.(b)(4), serial number (b)(4)).Customer states they inspected the plate in an attempt to find a colony that could possibly have identified as brucella, and they could not locate one.The customer also indicated they could not reproduce the brucella result.Summary: date of testing: (b)(6) 2023.Wound culture.Expected result: unknown.However, all isolates on media plate gram-stained as gram-positive cocci or gram-positive bacillus, resembling diptheroids.Result obtained : brucella spp.99.9 %.Media and incubation : bap media, incubation period : approximately 30 hours.There is no indication or report from the laboratory that the suspect result led to any adverse event related to any user's or patient's state of health.
Additional Manufacturer Narrative
A customer in the united states notified biomérieux of a suspected organism misidentification as brucella species in association with the vitek ms instrument (ref.410895, serial number (b)(6)).The customer also indicated they could not reproduce the brucella result.Vitek ms mode : ivd kb version : 3.2 (cli) us issue type : misidentification as brucella spp vitek ms result: lab id: # (b)(6) - no identification - single choice to brucella ceti/pinnipedialis - single choice to staphylococcus aureus other method : unknown expected id: unknown as no identification reference method was performed culture conditions: - origin: wound - culture media : bap media - incubation: approximately 30 hours - spotting tool: pickme pen investigation: fine tuning: status was good at the time of acquisition.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.Spot preparation should be verified with the customer.Knowledge base (kb) review: the expected identification is unknown because no reference method was performed to confirm the expected identification.Sample data analysis: analysis of mzml sample files shows that the spectra (i4) which gave the misidentification to brucella spp have the lowest number of peaks (36 peaks) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (30).Moreover, this misidentification was obtained with a low identification score (-0.11) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator¿).The 3rd spectra (a2), providing an identification as staphylococcus aureus, was very different than the others.It seems to be s different strain.Related to the misidentification as brucella, biomérieux global customer service csn # (b)(4) was published regarding potential misidentification as brucella spp with kb v3.2.Thus far, these incorrect organism identifications have been seen in conjunction with degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).Improvements will be implemented with the next vitek ms kb v3.3.According to the user manual 161150-925-a - vitek® ms v3.2 kb - clinical use, as brucella spp is a highly pathogenic organism, handle isolate with extreme caution and send it to a reference laboratory for further investigation.3.Root cause analysis - non optimal spot preparation - kb weakness linked with the bad quality of spectra 4.Corrective or preventive actions no capa number is needed.No further investigation activities can be performed without strain submittal.
Event or Problem Description
Intended use: vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mold infections.Description of issue: a customer in the united states notified biomérieux of a suspected organism misidentification as brucella species in association with the vitek ms instrument (ref.410895, serial number (b)(6).Customer states they inspected the plate in an attempt to find a colony that could possibly have identified as brucella, and they could not locate one.The customer also indicated they could not reproduce the brucella result.Summary: date of testing: (b)(6) 2023 wound culture.Expected result: unknown.However, all isolates on media plate gram-stained as gram-positive cocci or gram-positive bacillus, resembling diptheroids.Result obtained : brucella spp.99.9 % media and incubation : bap media, incubation period : approximately 30 hours there is no indication or report from the laboratory that the suspect result led to any adverse event related to any user's or patient's state of health.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Common Device Name: VITEK MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood 63042
• MDR Report Key: 16751817
• Report Number: 9615754-2023-00025
• Device Sequence Number: 20976482
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 410895
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown