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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Biomérieux internal investigation was conducted for patient isolates received from the customer for events 1 - 5.Investigations for events 6 and 7 are pending.Event #1 [misidentification of streptococcus anginosus (neqas survey samples) as streptococcus sanguinis]: investigational testing included: sequencing (soda): identification to the species streptococcus anginosus; vitek® 2 gp id (two customer lots and one random lot): identification to streptococcus sanguinis, or low discrimination between streptococcus anginosus and streptococcus sanguinis; vitek® ms: identification to the species streptococcus anginosus; api® 20strep: identification to the species streptococcus anginosus; rapid id 32 strep: identification to the species streptococcus anginosus.The investigation concluded that the neqas strain is an atypical strain for vitek® 2 system rapid phenotypic ast testing method.Neqas strains are often rare in order to challenge various test methods.Genetic measurement techniques (sequencing and mass spec) and non-automated methods such as api® and disc diffusion are more conducive to testing organisms exhibiting the observed growth behavior.Event #2 [misidentification of streptococcus milleri for a patient isolate]: the patient isolate was submitted to biomérieux and investigation was conducted.The investigation did not reproduce the customer misidentification.The low discrimination results of the vitek® 2 gp id card included the correct result of streptococcus constellatus.The investigation concluded the vitek® 2 gp id cards are performing in accordance with specifications.Event #3 [misidentification of streptococcus salivarius (atcc® 19258 tm qc organism) as streptococcus thermophilus]: review of product labeling confirmed all of the vitek® 2 id card product information chapters include a statement similar to the following: "the gp card typically identifies the quality control organisms as one-choice or within a low discrimination or slashline identification.However, strains are chosen for reaction performance over identification performance, so an unidentified or misidentified result may occur when all expected quality control reactions are correct." qc focus is on the individual expected well reactions.Clsi document m50-a ("quality control for commercial microbial identification systems; approved guidelines") provides further explanation.In addition, atcc® 19258 tm is now called streptococcus salivarius ssp.Thermophilus atcc® 19258 tm.Event #4 [misidentification of streptococcus pyogenes (atcc® 19615 tm) as gemella morbillorum]: the vitek® 2 gp id card uses seven (7) tests (adh1, aglu, phos, lac, novo, dtre, adh2s) to separate streptococcus pyogenes from gemella morbillorum.These seven tests should be positive for streptococcus pyogenes which indicates that gemella morbillorum is less reactive in the gp id card than streptococcus pyogenes.Therefore the result the customer obtained was less reactive than is normal for streptococcus pyogenes in the gp id card.Streptococcus pyogenes atcc® 19615 tm was tested during the development of the vitek® 2 gp id knowledge base and provided excellent results as streptococcus pyogenes.The customer did not comply with biomérieux request for isolate and raw data submittal.Without the strain, lab report and/or raw data, it is not possible to determine the cause of the misidentification.Evaluation of manufacturing batch records indicated vitek® 2 gp id lot 242374940 passed qc performance testing.There were no issues observed on initial qc performance testing.Based on the investigation, the vitek® 2 gp id card performed in accordance with specifications.Event #5 [misidentification of enterococcus faecalis]: investigational testing included:- 16s sequencing: identification to the species enterococcus faecalis; vitek® 2 gp id (customer lot and random lot): identification to vibrio fluvialis, or enterococcus casseliflavus; api® 20 strep: identification to the species enterococcus faecalis.The investigation concluded that the patient isolate strain is an atypical strain for vitek® 2 system rapid phenotypic ast testing method.Genetic measurement techniques (16s sequencing) and non-automated methods such as api® and disc diffusion are more conducive to testing organisms exhibiting the observed growth behavior.Evaluation of manufacturing batch records indicates vitek® 2 gp id lot 242374940 passed qc performance testing.There were no issues observed on initial qc performance testing.The investigations concluded the vitek® 2 gp id card is performing as intended and within the scope of product specifications.Device not returned to manufacturer.

Event Description

This report summarizes (b)(6) malfunction events.A review of the events indicated that testing via the vitek® 2 gram positive (gp) identification (id) test kit resulted in organism misidentifications.Eight (8) occurrences of a misidentification of streptococcus anginosus ((b)(6)) as streptococcus sanguinis; one (1) occurrence of a misidentification of streptococcus milleri (patient isolate); one (1) occurrence of a misidentification of streptococcus salivarius as streptococcus thermophilus; one (1) occurrence of a misidentification of streptococcus pyogenes (atcc® 19615 tm) as gemella morbillorum; one (1) occurrence of a misidentification of enterococcus faecalis; one (1) occurrence of a misidentification of streptococcus pneumoniae; two (2) occurrences of a misidentification of enterococcus faecium.About six (6) of the events involved patient organism identification test results.None of the events led to any adverse event related to a patient's state of health.About nine (9) of the events involved (b)(6) samples and were not associated with any patient.Culture submittals and raw test data were requested for each event.

• 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5596878
• MDR Text Key: 43295160
• Report Number: 1950204-2016-00043
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: K952095
• Number of Events Reported: 15
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 04/30/2016

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 Catalogue Number: 21342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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