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 from (b)(6) notified biomérieux of misidentification results when testing staphylococcus schleiferi with the vitek® ms instrument (ref 410895).The customer reported that the isolates from six blood culture bottles (three aerobic and three anaerobic) from the same patient were identified as alloiococcus otitis 99.9% by vitek ms.These results were reported to the clinician.A second series of blood cultures were drawn from this patient, and the organism was identified by vitek ms as low discrimination staphylococcus schleiferi 50%/alloiococcus otitis 50%.The customer performed vitek® 2 identification testing on isolates from different blood culture bottles and obtained staphylococcus schleiferi 93% and staphylococcus schleiferi 99%.The customer reported that there was no patient harm or incorrect treatment due to the discrepant result.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated for a customer report of misidentification results when testing staphylococcus schleiferi with the vitek® ms instrument (ref 410895).The investigation included review of customer data and testing of the isolate submitted by the customer.Conclusion on the system: the system was operational during the tests ("all peaks" and "good peaks" numbers from calibrator were conform).Conclusion on the isolate identification: based on the investigation results, the most probable identification is staphylococcus schleiferi.Investigation findings : the results obtained by reprocessing the customer data with the next vitek ms knowledge base (kb) v3.2 were improved and are aligned with vitek 2 results (staphylococcus schleiferi).Additionally, biomérieux tested the customer strain, and it was identified as staphylococcus schleiferi.They did not reproduce the customer's identification issue.Review of the customer's data concluded that the misidentifications had multiple causes: quality of the deposit (as the customer obtained one misidentification to staphylococcus aureus, a cross-contamination is suspected ; heterogeneity of the number of peaks for sample spots ; dissimilarity between spectra).Improvements have been made in vitek ms kb v3.2 as compared to vitek ms kb v3.0 for this species.

• 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: 8254494
• MDR Text Key: 134860657
• Report Number: 9615754-2019-00004
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1