MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS; VITEK MS INSTRUMENT

Model Number 410895

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of a group g streptococcus as a group a streptococcus when testing a patient isolate with the vitek® ms (ref 410895, serial (b)(4).The isolate was collected from a cerebral spinal fluid (csf) sample.The initial result of a group a streptococcus was reported to the physician.The patient was already being treated with vancomycin and meropenem and subsequent antimicrobial susceptibility testing (ast) results showed the organism to be susceptible to vancomycin.Repeat analysis with the vitek® ms was performed and obtained the identification of a group g streptococcus.The report to the physician was updated to include both the group a streptococcus and group g streptococcus organism identifications.Ast results for the group g streptococcus were also susceptible for vancomycin.The customer reported that the initial misidentification did not lead to any adverse event related to the patient's state of health as treatment for both organisms was the same.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Biomérieux investigation was conducted.Despite of several requests by biomérieux to the customer, raw data necessary to investigate were not provided.Conclusion on the fine tuning: the fine tuning analyzer report from the last fine tuning done before the identification issue has not been provided.Consequently, it was not possible to conclude on the fine tuning quality before the identification issue.The analysis of the calibrator mzml files indicates that no fine tuning was needed uring the tests made on (b)(6) and (b)(6) 2019.Conclusion on spot preparation quality: the customer's spot preparation quality was not optimal.The calibrator and sample "all peaks" values are heterogeneous.This could be explained by a non-optimal spot preparation (culture, spot, new user).Conclusion on the organism identification: with the information provided by the local customer service, the expected identification is streptococcus dysgalactiae ssp dysgalactiae/ streptococcus dysgalactiae ssp equisimilis.The discrepant result was obtained from the spectra having a lower number of peaks (51).Moreover, the identification was obtained with a low identification score (-0.31) which is near the acceptable limit for giving an "identification" result or a "no identification" result (-0.4).Note: "interpretation of results and use of the vitek ms system require a competent laboratory technologist who should judiciously make use of experience, sample information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth in an aerobic or a co2 atmosphere, should be considered when accepting vitek ms results.Review the context of your result to determine whether the vitek ms identification is consistent with your environment." suspected cause retained: non optimal spot preparation.

• Brand Name: VITEK® MS
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9252351
• MDR Text Key: 219774250
• Report Number: 9615754-2019-00115
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1