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 streptococcus dysgalactiae ssp equisimilis as streptococcus agalactiae in association with the vitek® ms (ref 410895, serial (b)(4)).Remel¿ pathodxtra¿ streptococcus grouping tests were used as an alternative method.Pathodxtra¿: streptococcus dysgalactiae ssp equisimilis.Vitek® ms: streptococcus agalactiae.The customer indicated that the misidentification did not lead to any adverse events related to the patient's state of health.The incorrect identification was not reported to the physician.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in finland regarding multiple misidentifications of streptococcus isolates as streptococcus agalactiae in association with the vitek® ms (ref 410895, serial 50459).Remel¿ pathodxtra¿ streptococcus grouping tests were used as an alternative method.Pathodxtra¿: streptococcus dysgalactiae ssp equisimilis.Vitek® ms: streptococcus agalactiae.An internal biomerieux investigation was performed.Conclusion on the fine tuning: the analysis of the calibrator mzml files indicates that a fine tuning was needed during the tests made on (b)(6) 2019.A new fine tuning was done on (b)(6) 2019.Conclusion on spot preparation quality: the customer's spot preparation quality is good during the period of the tests.The calibrator and sample "all peaks" values are quite homogeneous.Conclusion on the identification: isolate 19nn29334: regarding the complaint description, the expected identification is streptococcus dysgalactiae / equis (group c streptococci).As s.Agalactiae is a group b, misidentifications results are suspected for this isolate with vitek® ms.The customer's data reprocessed with vitek® ms knowledge base (kb) v3.2 eliminatd the suspected misidentifications for this isolate : s.Agalactiae result was changed into "no identification" result.However, to confirm the identification of these isolates, the reference method has to be done (sequencing).In addition, it is suggested to retest the isolates with the instrument recently fine tuned.Suspected cause: lack of system monitoring.

• 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: 9316329
• MDR Text Key: 219775851
• Report Number: 9615754-2019-00123
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1