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

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in the united states contacted biomérieux to report a misidentification of streptococcus bovis as lactococcus raffinolactis in association with the vitek® 2 gram-(b)(6) identification (id) test kit; patient specimen was from two (b)(6) blood culture bottles.Upon receipt of the lactococcus raffinolactis result, the treating physician requested the specimen be sent to a reference laboratory for additional testing; the result reported from the reference laboratory was streptococcus bovis.There is no indication or report from the laboratory or treating physician that the discrepant result led to any adverse event related to the patient's state of health.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer the united states reported a misidentification of streptococcus bovis as lactococcus raffinolactis or unidentified in association with the vitek 2 gp id test kit.Subsequent sequencing test by the customer identified the isolates as streptococcus bovis group.Biomérieux investigation was conducted.Two isolates submitted by the customer were subcultured and after 24 hours of incubation, two distinct colony morphologies were observed for (b)(6).One morphology was determined to be staphylococcus and was not tested.The remaining colony morphology and (b)(6) were tested on vitek 2 gp id cards from the customer lot, random lot, and api 20 strep.- (b)(6): gp id cards gave three low discrimination calls streptococcus infantarius/streptococcus gallolyticus, and one low discrimination call of streptococcus alactolyticus/streptococcus infantarius/streptococcus hyointestinalis.- (b)(6): gp id cards gave low discrimination calls streptococcus infantarius/streptococcus gallolyticus twice, and streptococcus alactolyticus/streptococcus infantarius twice.- the api 20 strep testing resulted in good identification of streptococcus gallolyticus for both isolates.The low discrimination calls are acceptable as streptococcus infantarius, streptococcus gallolyticus and streptococcus alactolyticus all belong to the streptococcus bovis group, which is an older taxonomy for several species claimed by the gp id card.Review of the lactococcus raffinolactis data against expected reactions for streptococcus gallolyticus demonstrated one atypical reaction (amy) contributing to the misidentification.The investigation concluded the vitek 2 gp id cards are performing as expected.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• 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: 5933167
• MDR Text Key: 54096101
• Report Number: 1950204-2016-00120
• 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: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242394510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1