MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE (GP) TEST KIT

Catalog Number 21342

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 the (b)(6) notified biomerieux of a misidentification with the vitek 2 gram-positive (gp) test kit (reference 21342).The customer reports a misidentification of s.Pneumoniae as kocuria rosea on the vitek 2; in addition, the customer reports several unidentified results obtained.The customer reports that all misidentification's, outside of expectation, by the vitek 2 are verified using optochin discs.The customer reports having good 24 hour culture growth on columbia horse blood agar (chba); in addition, they load the cards immediately on the vitek 2 once the suspensions are made.Based on the information provided there was no adverse events or negative patient impact; however, there was >24 hour delay in results.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the (b)(6) reported the occurrence of a misidentification of streptococcus pneumoniae as kocuria rosea in association with the vitek® 2 gp id test kit.The organism identification was confirmed via optochin disc.The customers testing was performed from columbia horse blood agar (chba); this is not a validated media for use with the vitek® 2 testing method.Retest using trypticase sheep blood agar (validated media) provided the expected result of streptococcus pneumoniae.Biomérieux investigation was conducted.Testing included: vitek® ms: identification to streptococcus pneumoniae (99.9%), we confirmed the expected result.Vitek® 2 (customer lot): identification to streptococcus pneumoniae on one card, low discrimination streptococcus pluranimalium/erysipelothrix rhusiopathiae/gardnerella vaginalis on one card (the package insert instructs to perform an alternate method of testing for low discrimination identifications).Vitek® 2 (random lot): identification to streptococcus pneumoniae (both cards).Rapid id 32 strep: identification to streptococcus pneumoniae 98.5%.The investigation did not duplicate the customer misidentification of kocuria rosea.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) TEST KIT
• Type of Device: VITEK® 2 GRAM-POSITIVE (GP) TEST KIT
• 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5809311
• MDR Text Key: 50080318
• Report Number: 1950204-2016-00075
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242383840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1