MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of micrococcus luteus/lylae as arcanobacterium haemolyticum in association with the vitek® ms system.The customer stated there was no impact on patient reporting; there was a minor delay since they had to repeat testing.In addition, the customer reported the occurrence of a group c streptococcus misidentified as streptococcus pyogenes.Reports were not sent out to the physician.Customer repeated testing and performed agglutination tests for confirmation; confirmatory testing via agglutination returned a result of group g streptococcus.The log files from the vitek® ms were submitted for evaluation.The results indicated that fine-tuning, spot preparation, and/or culture conditions may have caused the misidentification.When the misidentification occurred, "all peaks" criteria and "good peaks" criteria were below the threshold.The local field service engineer visited the customer site and performed a fine-tuning procedure.Subsequent specimen testing by the customer indicates the issue now seems to be resolved.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in canada experienced a misidentification of micrococcus luteus/lylae as arcanobacterium haemolyticum in association with the vitek® ms system.Internal biomérieux investigation was performed.The investigation concluded that the issue occurred as a result of poor/inconsistent spot preparation.The data log analysis indicates the initial tests performed by the customer show only 25 and 33 peaks are present, while the repeat spots show 53 and 55 peaks present, respectively.Lower peak counts can lead to organism misidentification.As a precaution, instrument fine-tuning was performed.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6063510
• MDR Text Key: 59016108
• Report Number: 3002769706-2016-00455
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1