MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK® MS INSTRUMENT

Model Number 410895

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

There were no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.Investigation the investigator reviewed the complaints database in search of any similar issues which had been previously reported.Since january 2016, no similar complaint has been recorded for a cocci isolate being misidentified as bacillus anthracis.No capas nor non-conformities on vitek® ms can be linked with customer 's complaint.Fine tuning: fine tuning appeared to be good at the time.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review: the expected identification remains unknown because no reference method was used to confirm the identification.Sample data analysis: according to data provided, the misidentification result was obtained from the spectra having a low identification score (-0.35) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).The spots a1 and a2 were performed with the fungi protocol (with formic acid).These results cannot be taken into account as it is an off-label use for bacterial strain.The vitek® ms v3.0 knowledge base user manual ref.161150-556-b documents the following: ¿*refrain from testing suspected b.Anthracis on the vitek ms system.*perform additional tests using other identification methods in the event of an identification result reported by the vitek ms system as b.Anthracis.¿ the true organism identification could be a species out of vitek ms knowledge base.The customer strain will not be submitted to biomérieux as it could be a pathogenic strain.The customer needs to confirm the strain identification by sequencing (which is the reference method) in these cases.In addition, the following system limitation is stated in the vitek ms v3.0 knowledge base user manual ref.161150-556-b: ¿* testing of species not found in the database may result in an unidentified result or a misidentification.Interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ conclusion: the investigator concluded the customer¿s issue was due to non-optimal spot preparation in combination with a known system limitation regarding species which are not part of the knowledge base library version.Local customer service provided additional training materials to the customer to help improve the spot preparation technique and discussed the importance of following the correct protocol (bacteria vs yeast) to obtain correct identifications.Customer service also provided information regarding vitek® pickme¿ (ref 423551/ 423546) to further assist with sample spot preparation.The investigator also recommended update of the customer¿s vitek® ms knowledge base with the latest version (kb (b)(4)).

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of a suspected catalase neg.Gram pos.Cocci as bacillus anthracis in association with the vitek ms instrument (ref.410895, (b)(4)) for one patient sample.The sample from a wound at the temple was incubated in anaerobic environment on cos agar from oxoid for 48 hours.Summary of results: mzml from 11:20 bacillus anthracis, spot without fa (formic acid).Mzml from 14:28 no id, spots with fa.The "no id" result from this sample was reported.On the agar plate, the sample didn¿t appear as b.Anthracis;, it appeared more like catalase neg.Gram pos.Cocci.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.

• 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
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13111501
• MDR Text Key: 286269623
• Report Number: 9615754-2021-00302
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• 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: A
• Patient Sequence Number: 1