MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GP TEST KIT; VITEK® 2 GP TEST CARD

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of a fackmalia languida external quality control sample in association with the vitek® 2 gp test kit.The sample was twice tested with the vitek® 2 gp and the result was kocuria rosea at 97% and 99%.The customer also tested the sample twice using vitek® 2 anc cards; the first provided a result of "unidentified", and the second obtained an identification to corynebacterium jekyum.The test reports and isolate were requested from the customer.A biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had reported to biomérieux the misidentification of a fackmalia languida external quality control sample in association with the vitek® 2 gp test kit.The sample was tested twice with vitek 2, and the result was kocuria rosea at 97% and 99%.An internal biomérieux investigation was performed.The sample tested was a ctcb qc strain ( ctcb qc survey strain 1631).Ctcb information : identification to the species for 20.5% of participants and to the genus for 29.4 % (no details on products used).Sequencing testing was performed, and the expected identification was confirmed: facklamia languida.Testing was performed with vitek 2 gp cards including customer lot (cl: 2420029103) and a random lot (rl: 2420043103), the sample was sub-cultured on cba.Vitek 2 obtained a very good identification or excellent identification to the species kocuria rosea (cl & rl with cba subculture).Facklamia languida is not in the gp knowledge base of vitek 2.The customer's misidentification to kocuria rosea on the vitek 2 gp card was duplicated.Nevertheless, vitek 2 notified with bioart rule: " possibility of low reactive strain , check methodology and identification" there is a limitation on vitek 2 for species not claimed in the knowledge base: testing of unclaimed species may result in an unidentified result or a misidentification.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6316124
• MDR Text Key: 67328551
• Report Number: 1950204-2017-00049
• 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: 02/06/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: 02/13/2017
• Supplement Dates FDA Received: 02/06/2018
• 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: N
• Patient Sequence Number: 1