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  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of a patient isolate (streptococcus alpha haemolysis) as streptococcus agalactiae or streptococcus constellatus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Alternate testing via thermofisher latex strepto b exhibits no agglutination (negative for streptococcus b organism).The customer indicated a delay >24 in reporting results to the physician.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 from the customer for bioméreiux investigation testing.Biomérieux investigation will be conducted.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: this investigation was initiated due to a misidentification of streptococcus constellatus as streptococcus agalactiae on vitek®2 (v7.01) gp cards.The reference method (sequencing soda) used to determine the intended result, and api 20 strep strip are in favor of the species streptococcus constellatus spp constellatus.We tested gp cards on vitek®2 (v7.01) with the customer lot (cl : 2420177203) and a random lot (rl : 2420157103) on cba subcultures.Then we compared the results -on cl : we obtained a low discrimination between streptococcus agalactiae and streptococcus gordonii -on rl : we obtained an excellent identification to streptococcus agalactiae (99%) the customer misidentification result was reproduced.We observed 2 atypical reactions (bgal & lac for customer and tyra & lac in house).This is an atypical strain.

• 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: 6361221
• MDR Text Key: 68418899
• Report Number: 1950204-2017-00070
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420177203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2016
• 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