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

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) contacted biomérieux to report a misidentification of geobacillus stearothermophilus atcc® 12978¿ as geobacillus caldoxylosilyticus in association with the vitek® ms plus system.The customer stated that they use geobacillus stearothermophilus atcc® 12978¿ with the vitek ms plus.For two consecutive days, each day with three (3) spots tested, the vitek ms plus 3.1 obtained the expected organism id result for two (2) spots and the incorrect result geobacillus caldoxylosilyticus for one (1) spot.Evaluation of the mzml data files corresponding to the discrepant tests performed by the customer indicates that the customer's spot preparation was not optimal.Evaluation of the fine tuning data showed that the "all peaks" number was slightly elevated with regards to what is expected.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the atcc strain.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification of a misidentification of geobacillus stearothermophilus atcc® strain in association with the vitek® ms instrument.Biomérieux investigation was conducted.Data files were analyzed, and field service engineer (fse) intervention was accomplished.Conclusion on the system function: the system was operational.For information, the "all peaks" count is higher than the target value requested during fine tuning (123 instead of 110).The customer's spot preparation quality is not optimal.The calibrator "all peaks" count is heterogeneous.Important mass shifts (around 2000ppm) were observed when comparing the peak lists (i.E.Spectra) from the three sample spots.The investigation confirmed that these mass shifts explained the misidentification.Additionally, it was determined the mass shifts were due to the use of a prior version of the vitek ms acquisition software.The customer was using version 1.5.0.3 instead of 1.5.0.4; this was due to human error as the update instructions were not followed.The system was updated to version 1.5.0.4 and no further misidentifications have been encountered.Following fse intervention, the customer's vitek ms system is fully operational and performing to specification.

• Brand Name: VITEK MASS SPECTROMETER
• Type of Device: VITEK® MS¿ PLUS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 7953573
• MDR Text Key: 125463221
• Report Number: 3002769706-2018-00207
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1