MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT; VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT, PRODUCT CODE

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the united states contacted biomérieux to report a misidentification of an organism streptococcus dysgalactiae as streptococcus agalactiae in association with the vitek® 2 gram-positive (gp) identification (id) test kit involving a patient sample.The incorrect results were reported to the physician, however the misidentification of the organism did not impact the patient or lead to a delay in patient treatment.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A biomérieux investigation was conducted for a gram-positive cocci that was submitted for vitek® 2 evaluation because the gram-positive card gave an excellent id of streptococcus agalactiae.However, when the organism was tested on the bruker maldi tof, an identity of s.Dysgalactiae was obtained.Additionally, pathodx strep typing identified the organism as group c strep.The organism was subbed and testing included 1 card from the customer lot of gp cards, along with 2 random lots.Api strep was also performed, as was streptococcus latex grouping.On all 3 cards tested, an excellent id (99%) of s.Agalactiae was obtained.Api strep gave an excellent id (99.9%) of s.Dysgalactiae ssp equisimilis.Additionally, streptococcus latex grouping identified the organism as a group c strep.A comparison of card reactions against the expected reaction results for s.Dysgalactiae ssp equisimilis revealed 1 atypical positive reaction (baci) which led to the misidentification.The isolate exhibited atypical growth behavior.The investigation concluded the vitek® 2 gp id test kit performed as intended.A review of quality records showed there was no other complaint for this issue.No further action is required.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT, PRODUCT CODE
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6158135
• MDR Text Key: 62384826
• Report Number: 1950204-2016-00200
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420071103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1