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

Catalog Number 410895

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer notified biomerieux that they had a mis-identification when using the viteks instrument.Two samples were taken from the same patient.The first sample was identified as streptococcus pneumoniae.The second sample was identified as streptococcus mitis/oralis.No confirmatory or alternate testing was performed by the laboratory.When specifically asked, the customer was unaware of any injury or death associated with this event.The customer did indicate a delay in reporting results of an indeterminate time.An investigation has been initiated by biomerieux to investigate this event.

Manufacturer Narrative

A customer notified biomerieux that they had a mis-identification when using the vitek ms instrument.An internal biomérieux investigation was performed.A blood culture patient isolate was identified on the vitek ms ivd with two (2) different results: streptococcus pneumoniae or streptococcus mitis/oralis.Sample mzml files associated with two (2) accession numbers were provided for investigation: (b)(6).These are from the same patient but different plates.The correct identification should be streptococcus mitis/oralis.Vitek 2 confirmed that accession # (b)(6) is streptococcus mitis/oralis.-fine tuning: samples tested on 13, 14 and (b)(6) 2016, last fine-tuning date : (b)(6) 2016.-culture conditions: blood agar, 35°c at co2, pure colonies.Investigation conclusion: out of the 17 tests performed by the customer on this strain: - 10 gave the correct result s.Mitis/oralis - the system performed as expected - five (5) gave no identification - the system performed as expected giving noid because the spectrum was not optimal - two (2) gave a misidentification s.Pneumoniae.- results for which this investigation was opened.The last fine tuning was done the day before the misidentification occured (fine tuning done on (b)(6) and misidentifications obtained on (b)(6)).The fine-tuning criteria were met on (b)(6) 2016 whereas two (2) criteria (good peak and identification score) were under the target when analyzing the ecal mzml from (b)(6) 2016.It was noticed that the number of "all peaks" is heterogeneous, this could be due to sample preparation issue.In this case, non-optimal quality spectra could be generated and analyzed by the system.Customer's spectra were analyzed.Investigation showed that customer's spectra calibrated manually to suppress this defect gave the correct identification str.Mitis/oralis instead of misidentifications.Note that the risk associated with this software defect has been assessed to minor for vitek ms v2 and has already been corrected with vitek ms v3.Moreover, the customer's strain was tested internally on vitek ms v2 (version used by the customer) and vitek ms v3 (next system version), results are : - v2: 2 correct identifications and one (1) low discrimination including s.Mitis/oralis - v3: 2 correct identifications and one (1) noid.The misidentification obtained by the customer was not reproduced internally.The customer's misidentification is most likely caused by sample preparation issue.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6029712
• MDR Text Key: 57558850
• Report Number: 3002769706-2016-00444
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

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 Catalogue Number: 410895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1