MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MASS SPECTROMETER; VITEK® MS¿

Model Number 410895

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) contacted biomérieux to report the occurrence of a misidentification of group a strep as streptococcus dysgalactiae in association with the vitek® ms system.The customer stated that in addition to the streptococcus strain,the inoculated media displayed growth of staphylococcus aureus, acinetobacter baumannii and enterobacter cloacae.They isolated the strep on a blood plate and observed hemolysis.Vitek ms provided a result of streptococcus dysgalactiae ssp equisimilis/ streptococcus dysgalactiae ssp dysgalactiae.Alternative method testing (pathdx2, oxoid and novamed strep a stick) provided results of "positive" for group a strep.Bruker ms gave streptococcus dysgalactiae but with a remark to check also for streptococcus pyogenes.The customer stated that the vitek ms result was not reported to the physician; therefore had no effect on patient treatment decisions.There was a delay of undisclosed duration in reporting the correct result.The customer also indicated there was no adverse impact to the patient's state of health.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in israel contacted biomérieux to report the occurrence of a misidentification of group a strep as streptococcus dysgalactiae in association with the vitek® ms system.An internal biomérieux investigation was performed.The customer strain was not submitted for evaluation.All data provided from the tests performed were analyzed.Conclusion on the system: => system was operational during the tests.=> the customer's spot preparation quality was non-optimal.The "all peaks number" from the calibrator strain is quite heterogeneous - it can be extrapolated to sample spot preparation.Conclusion on the identification: based on the complaint description, the most probable identification is group a streptococcus.To confirm the identification to the species name, molecular method has to be performed (it is considered as the reference method).Vitek ms gave low discrimination to s.Dysgalactiae ssp dysgalactiae - s.Dysgalactiae ssp equisimilis for this strain.Streptococcus dysgalactiae ssp equisimilis are (mostly) beta-haemolytic and can harbor carbohydrate antigens of lancefield group a, c, g or l.So vitek ms results are not inconsistent with complementary tests.Furthermore, vitek 2 and bruker testing gave the same result as the vitek ms.

• Brand Name: VITEK MASS SPECTROMETER
• Type of Device: VITEK® MS¿
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 7818868
• MDR Text Key: 119034109
• Report Number: 3002769706-2018-00169
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• 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: 09/26/2018

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: 410895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1