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

In (b)(6) 2016, a customer in (b)(6) contacted biomérieux to report misidentification of a patient isolate (streptococcus uberis) as streptococcus agalactiae in association with the vitek® ms.The vitek® 2 gram-positive (gp) identification (id) test kit had identified the organism as streptococcus uberis.The customer stated this streptococcus ubseris identification was correct.A medwatch 3500a (3002769706-2016-00099) was submitted (b)(6) 2016 regarding the claim of vitek® ms malfunction.Biomérieux internal investigation was conducted.Through comparison testing and statistical analysis of the vitek® ms result spectra, the investigation concluded the vitek® ms identification to streptococcus agalactiae was in fact the correct identification.A new complaint record was initiated to document the vitek® 2 gp id malfunction (misidentification to streptococcus uberis).There is no indication or report from the laboratory or physician that the discrepant vitek® 2 gp id test result led to any adverse event related to any patient's state of health.Biomérieux investigation will be conducted.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: sequencing soda confirmed the identification to the species streptococcus parauberis for the four (4) strains tested internally.Vitek® ms results from qc: vitek® ms v2.0 did not perform as intended for these four (4) strains.The intended species streptococcus parauberis was not in the knowledge base (kb) of v2.0.Vitek® 2 cards were performed and did not identify streptococcus parauberis as this species is not included in the vitek® 2 database.There is a limitation for species not claimed in the knowledge base (kb): testing of unclaimed species may result in an unidentified result or a misidentification.

Manufacturer Narrative

Internal biomérieux investigation was conducted in relation to misidentification of five (5) streptococcus agalactiae strains as streptococcus uberis in association with the vitek® 2 gp id test kit.Sequencing soda, the reference method used to determine the intended result, identified all strains to streptococcus agalactiae.Vitek® 2 gp id testing included two random lots (the customer lot was expired at the time of investigation testing).Four (4) of the strains identified to the organism streptococcus agalactiae for both lots tested.One (1) of the strains identified to streptococcus agalactiae for one of the lots, and to a low discrimination between s.Agalactiae and s.Dysgalactiae ssp equisimilis for the other lot.Vitek® ms identified all five (5) strains to streptococcus agalactiae.The misidentification observed by the customer was not reproduced during the internal biomérieux investigation.The investigation concluded the vitek® 2 gp id test kit performed as intended.

• 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: 6435719
• MDR Text Key: 70998056
• Report Number: 1950204-2017-00098
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242351110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2015
• 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