MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT; VITEK® MS INSTRUMENT

Model 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 from the united states notified biom¿rieux of obtaining a misidentification of a patient isolate when testing with the vitek¿ ms instrument (ref.410895, (b)(4)).Initial vitek ms testing of the patients isolate obtained an identification of bacillus cereus and a no identification result.The customer said that the microorganism was identified as gram-positive cocci (gpc).The result obtained with vitek ms was not consisted with the gram stain result.Upon retesting with vitek ms, the customer obtained a result of actinomyces odontolyticus.There is no indication or report from the customer to biom¿rieux that the reported issue led to any adverse event related to the patient's state of health.An internal biom¿rieux investigation has been initiated.

Manufacturer Narrative

A customer in the united states notified biomérieux of obtaining an incorrect organism identification result in association with their vitek® ms instrument (ref.410895; serial# (b)(6).The initial test gave a single organism choice of bacillus cereus, however the sample was gram positive cocci (which is not consistent with b.Cereus.).A second spot of the sample gave a "no identification" result.Investigation: investigator reviewed the complaint database for reports of gram positive cocci misidentified as b.Cereus.There is no capa, no non-conformity for vitek ms linked with customer 's complaint.Since (b)(6) 2016, there have not been any other reports for this kind of misidentification.Fine-tuning: according to the vilink alert tool criteria, fine-tuning was needed during the tests made on (b)(6) 2020.Once they performed fine-tuning, the b.Cereus result was no longer observed.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review: the expected identification remains unknown as it was not confirmed using a reference method (i.E.Sequencing).Sample data analysis: the analysis of the mzml samples files show the identification was obtained with a low identification score ( -0.27) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).Root cause was determined to be non-optimal spot preparation and drift of the fine-tuning.It was recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique, as well as reviewing with them the procedure for fine-tuning.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11139520
• MDR Text Key: 228018078
• Report Number: 9615754-2021-00004
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1