MAUDE Adverse Event Report: BIOMERIUEX SA VITEK® MS INSTRUMENT

Model Number 410710

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) reported to biomérieux discrepant results associated with a vitek® ms instrument where a beta-haemolytic streptococcus (usually a group a, c or g) is identified by maldi as s.Agalactiae (group b).A representative from biomérieux checked the tuning files and the criteria were not in specification.After tuning the customer re-ran the isolate 4 times and in all occasions it id correctly.The customer reported that they already knew the results by the plate culture.These incorrect results were not reported to the patient although there was a slight delay in reporting the results as they had to wait a day for a biomérieux representative to service the instrument before retesting.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Result code: the correct code is 114 (operational problem).Conclusion code: the correct code is 63 (repaired and returned to user).

Manufacturer Narrative

An investigation was performed.Vitek ms result : s.Agalactiae (group b).Other identification method : unknown.Expected identification : group c streptococcus.Orientation tests : isolate does not grow on macconkey agar and has a large zone of haemolysis, all consistent with a group c streptococcus.Culture conditions : unknown.Last fine-tuning date : 17mar2017 conclusion on the system: 1.System was not operational during the test (fine tuning acceptance criteria did not conform).2.A slight spot preparation heterogeneity was detected but it is not significant.Conclusion on the identification: regarding the customer data, the most probable identification is group c streptococcus.This identification was confirmed by the customer with vitek ms after fine tuning.Suspected root cause of the issue: non-optimal fine tuning.The instrument was fine tuned and repeat testing obtained the expected results.Following this issue, a periodic follow-up of this system was implemented.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIUEX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 6522403
• MDR Text Key: 74146947
• Report Number: 3002769706-2017-00079
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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: 410710
• Device Lot Number: 60472/09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: 02/14/2018; 02/14/2018
• Supplement Dates FDA Received: 03/15/2018; 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1