MAUDE Adverse Event Report: BIOMERIEUX, S.A. VITEK MS INSTRUMENT

Catalog Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Type  Injury  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification associated with vitek ms instrument involving an elderly vietnamese male patient with a recurrent thigh abscess.The customer reported samples taken from the thigh abscess were tested using the vitek ms and resulted in either misidentification or no identification.Eventually, a sample was sent to an outside lab where it was identified as burkholderia pseudomallei.The customer reported that every technologist in the lab had been potentially exposed to the organism at some time over the last year.The plan is to arrange for serology with the cdc rather than offering blanket prophylaxis to the personnel.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: based on the data provided by local customer service (lcs) it is only possible to give the status of the system for the last identification result, performed on (b)(6) 2016: the system was not operational.Regarding the analysis of the data provided by lcs, the most probable identification is burkholderia pseudomallei.For information: burkholderia pseudomallei et mallei are part of the v3.3 package through a partnership with a laboratory p3.The suspected root cause of the issue is the system not being operational.There is a system limitation: b.Pseudomallei is not present in any of the vitek® ms knowledge bases (kb).Vitek® ms system identification is based on a species pattern classification.This system limitation is due to the use of a predictive modeling based on a supervised learning.Typically, such a model includes an algorithm that learns certain properties (e.G., presence of peaks) from a training spectra dataset in order to make those predictions.When the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison.Consequently, the system can give: no identification (no-id) (most probable answer) when the spectrum acquired does not match with any species pattern.An incorrect single choice identification to the nearest species pattern (often same genus as expected) when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.An incorrect low discrimination identification (often the same genus as expected) when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.This system limitation is mentioned in the following vitek® ms knowledge base (kb) user manuals: kb v2.0 clinical us: manual ref (b)(4), page 1-11 "testing of non-clinically validated species or species not found in the database may result in an unidentified result or a misidentification." kb v3.0 clinical ex-us: manual ref (b)(4) currently available only in english since 25-jan-2017 as: "testing of non-clinically validated species or species not found in the database may result in an unidentified result or a misidentification." recommended actions to the customer: perform a fine tuning.Install vilink in order to monitor the status of the instrument.Update the system to kb v3.3 whether as available.B.Pseudomallei, it should not be retested on the instrument after fine-tuning occurs.As reminder: according user manual ref (b)(4) (kb v2.0 clinical-exus) / ref (b)(4) (kb v3.0 clinical-exus): highly pathogenic organism: select agent (usa) - handle isolate with extreme caution and send to a reference laboratory for identification confirmation following your laboratory's select agent protocol.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6150725
• MDR Text Key: 61608785
• Report Number: 3002769706-2016-00503
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 410895
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention