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  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results when testing a burkholderia species isolate with the vitek® ms instrument.The burkholderia strain was isolated from a patient sputum sample.Vitek ms identified it as b.Cenocepacia, b.Cepacia, and b.Contaminants.The customer used macconkey media and cultured the isolate for 18 hrs in the 5% co2 incubator.The customer reported that the patient was immunosuppressed, and many microorganisms were isolated from a variety of specimen types.The customer also reported that the discrepant results did not delay the treatment or cause any harm to the patient.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: system was operational during testing.The customer's spot preparation was not optimal.The "all peaks number" from the calibrator strain is quite heterogeneous.It can be extrapolated to sample spot preparation.No correlation can be drawn between the sequencing results and vitek® ms instrument sample mzml files received.When the customer's data was reprocessed with latest knowledge base version (vitek ms kb v3.2), all results were the same except two tests: burkholderia lata with kb v3.0 is changed into burkholderia cepacia in kb v3.2.Suspected cause of the issue: it was not possible to link the sequencing results with vitek ms results.It is not possible to conclude what the root cause is of the suspected misidentification.

• Brand Name: VITEK MASS SPECTROMETER
• Type of Device: VITEK® MS¿
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 7812607
• MDR Text Key: 118558931
• Report Number: 3002769706-2018-00161
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• 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: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1