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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of facklamia languida (external control strain) as kocuria rosea in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Repeat testing obtained the same result.The external control strain, facklamia languida, is not claimed in the vitek® 2 gram-positive knowledge base.The gp id knowledge base will attempt to match the reactions of the tested isolate to claimed biopatterns.If an unclaimed species is tested and a close match is found, a misidentification can occur.If the biopattern does not match and a close match cannot be found, a result of unidentified will be reported.In this case, the reactions of the tested isolate matched kocuria rosea sufficiently enough to report the identification as such.The following limitation is indication in the instructions for use (vitek® 2 systems product information): "the vitek® 2 gp card cannot be used with a direct clinical specimen or sample or other sources containing mixed flora.Any change or modification in the procedure may affect the results.Newly described or rare species may not be included in the gp database.Selected species will be added as strains become available.Testing of unclaimed species may result in an unidentified result or a misidentification." there is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the external control strain.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of facklamia languida (external control strain) as kocuria rosea in association with the vitek® 2 gram-positive (gp) identification (id) test kit.An internal biomérieux investigation was performed.Biomérieux performed the sequencing and confirmed the expected result of facklamia languida.Testing included gp cards with customer lot (cl: 2420029103) and a random lot (rl: 2420043103), subcultured on cba.A very good identification or excellent identification to the species kocuria rosea (cl & rl with cba subculture) was obtained.Facklamia languida is not a claimed organism species in the vitek® 2 gp knowledge base.The current vitek® 2 product information manual (ref.(b)(4)) indicates which organisms can be identified using the vitek® 2 gp id card; facklamia languida is not listed.In addition, the vitek® 2 product information manual states the following for gram-positive identification: "newly described or rare species may not be included in the gp database.Selected species will be added as strains become available.Testing of unclaimed species may result in an unidentified result or a misidentification." for any organism placed into a test card, the vitek® 2 system will assess the card readings against the known organisms and provide an organism identification, if possible, based on a combination of growth well reactions.For results with a percent confidence of <99%, the customer must make a determination of acceptance or further testing based on the logical likelihood of the identification considering other laboratory and clinical factors.The investigation concluded the vitek® 2 gp id card is performing 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: 6091043
• MDR Text Key: 59781347
• Report Number: 1950204-2016-00170
• 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: 02/27/2017

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: 12/25/2017
• Device Catalogue Number: 21342
• Device Lot Number: 2420029103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2016
• 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