MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GP TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in colombia reported a misidentification of streptococcus agalactiae as streptococcus thoraltensis in association with the vitek 2 gp test kit.The customer reported the streptococcus agalactiae was confirmed by sample type, macroscopic features and biochemical series.The customer reported there was a delay in reporting the incorrect results.There is no indication or report from the customer to biomérieux that the discrepant result led to any adverse event related to a patient's state of health.It was noted that during the last service visit, the pre-analytical phase was revised, except for the culture media which are prepared by the customer, and greater deviation was found in the assembly process.Users claim that misidentification errors have occurred with multiple users since the last visit and that prior use of the same methodology did not produce errors.The vitek 2 instrument was newly installed in (b)(6) 2016.An internal investigation has been initiated.

Manufacturer Narrative

An investigation was conducted for a misidentification of streptococcus agalactiae as streptococcus thoraltensis in association with the vitek® 2 gp test kit.Information showed the customer was having identification issues with multiple species.Troubleshooting indicated that the customer prepared their own media, their saline may have been contaminated, and they did not test isolates at the appropriate age of culture.After a visit from a field service engineer to check the instrument, card set up, and review procedure, the identification issues ceased.Two lab reports were submitted for review.One lab report showed an acceptable identification of streptococcus thoraltensis.There were seven (7) atypical positive reactions (amy, draf, cdex, dxyl, dsor, dman, pul) for an identification of streptococcus thoraltensis.There were 5 atypical positive reactions (amy, draf, dxyl, dsor, pul) for an identification of streptococcus agalactiae according to the gp knowledge base.A review of quality records confirmed gp lot 242398140 met final release criteria and there were no issues with initial performance testing.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain.However without the strain, or raw data it's not possible to further evaluate the cause of the misidentification.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6138434
• MDR Text Key: 61245543
• Report Number: 1950204-2016-00192
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/09/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420044103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1