MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MASS SPECTROMETER; VITEK® MS

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  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of a beta hemolytic group b streptococcus as either low discrimination streptococcus dysgalactiae/streptococcus dysgalactiae equisimilis/streptococcus pyogenes, or a single choice call of streptococcus pyogenes in association with the vitek® ms system.Latex agglutination was negative for group a streptococcus, positive for group g streptococcus.The discrepant vitek® ms identification result was not reported to the treating physician; the vitek® ms result had no impact on patient treatment decisions.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states contacted biomérieux to report a misidentification of a beta hemolytic group b streptococcus in association with the vitek® ms system v2 (kb v2.0).An investigation was performed.The investigation reviewed the following data: the most recent fine tuning report performed 10mar2017 and the last fine tuning performed before the identification issue was done on 27feb2017.Twelve (12) sample mzml files (six "gram positive" from 08mar2017 to 10mar2017 and six "gram negative" from 04 mar2017, 05 mar2017, 07 mar2017 and 08mar2017) thirty-eight (38) ecal mzml files from 02mar2017, 03 mar2017, 08 mar2017 and 09mar2017.The most suspected root cause of the misidentifications appears to be due to spot technique.For the gram positive organism, the only spot that gave a misidentification had few peaks compared to the other files.The files indicating more peaks resulted in low discrimination results, but the correct organism was present as one of the choices.A similar explanation can be seen with the gram negative isolates.The files that gave the misidentifications had a good number of peaks, but the scores present were low which can be due to poor spotting.The files that gave the correct identification of e.Coli had higher scores which is indicative of better spots.The analysis of the files with updated knowledge base (kb v3.0) helped improve the results.A no identification would have been obtained instead of a misidentification.The new system version vitek ms v3 kb v3.0 reduces the risk to have a misidentification in case of non-optimal sample spot preparation.The acceptance criteria to give an identification has been increased for kb v3.0 (from -0,6 with kb v2.0 to -0,4 for kb v3.0).

• Brand Name: VITEK® MASS SPECTROMETER
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6459813
• MDR Text Key: 71750806
• Report Number: 3002769706-2017-00062
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• 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: 07/03/2017

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 Model Number: 410895
• Other Device ID Number: 03573026433147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: 06/06/2017
• Supplement Dates FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1