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

On (b)(6) 2021, a customer in (b)(6) notified biomérieux of obtaining a misidentification of listeria monocytogenes as listeria innocua species associated with vitek® ms instrument ref.410895, serial number(b)(4).The customer stated testing was also performed via filmarray®, and it identified the organism as listeria monocytogenes.The strain was sent to a reference laboratory for further confirmatory testing.A result of l.Monocytogenes, serogroup ivb was returned (testing method not disclosed).The customer indicated there were no negative effects on the patient as the vitek® ms result was not reported.L.Monocytogenes was reported to the physician based on filmarray (and later due to the confirmation of the culture result).

Manufacturer Narrative

A customer in germany notified biomérieux of obtaining misidentification of listeria monocytogenes as listeria innocua species in association with their vitek® ms instrument (ref.(b)(4), serial number (b)(6).Additional testing (bruker mass spectrometry; film array; typing result from robert koch institute; and culture characteristics) suggested the organism was l.Monocytogenes.The customer did not confirm the identification via a reference method (i.E.Sequencing).Investigation the investigator searched the historical complaint records for similar issues.Since january 2016, no other complaint has been recorded for misidentification of listeria monocytogenes as listeria innocua.Further, no capas nor non-conformities have been submitted against vitek® ms associated with the customer's reported issue.Fine tuning: according to vilink alert tool criteria, no fine tuning was needed during the tests made on 08 jan 2021.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.By analyzing calibrator spectra linked to the sample spectra (the potential misidentification), the investigator observed that both the calibrator and control spectra contained peaks of hemoglobin.This finding shows that the technician likely collected agar during spot preparation.This analysis confirms that the spot preparation was non optimal.It can be extrapolated to the sample spot preparation.Sample data analysis: reprocessing the customer data with vitek® ms kb v3.2 provided a single choice of listeria innocua and one ¿no identification¿ result.The listeria innocua result was obtained with a low identification score (-0.23) which is near the acceptable limit (-0.4) for giving an ¿identification¿ result or a ¿no identification¿ result.Biomérieux quality control laboratory did not reproduce the vitek® ms customer results.Using the submitted isolate, the laboratory obtained the expected identification l.Monocytogenes.The sample was submitted for sequencing in order to confirm the organism identification.The customer strain was identified as listeria monocytogenes using full-16s sequencing.This result is in accordance with biomérieux qc lab vitek® ms results, filmarray and bruker results.Root cause with a system used under the right specifications (optimal fine tuning and optimal spot preparation), vitek® ms was able to identify the strain as expected.In our case, it confirms that the issue was linked to a non-optimal spot preparation as no fine tuning was need during the customer tests.Conclusion no capa is required as the system is working as designed and intended.Local service reviewed sample preparation with the customer to help improve their spot preparation technique.They also suggested vitek® pickme (ref (b)(4) to the customer.

• 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: 11230946
• MDR Text Key: 240164837
• Report Number: 9615754-2021-00012
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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: 01/05/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1