MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of aeroococcus species as granulicatella adiacens in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Testing via mass spectometry obtained the aerococcus result.The customer indicated there was no adverse impact to the patient's state of health due to the discrepant vitek® 2 gp id result.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed due to a customer notification of a misidentification of an aerococcus sanguinicola strain on vitek® 2 (v7.01) gp id test kit (ref 21342).The reference method (sequencing full 16s) used to determine the intended result, gives an excellent identification to the species a.Sanguinicola (99.83%).On vitek 2 (v7.01) gp cards, one (1) card of the customer lot (2420462203 called cl) and one (1) card of a random lot (2420490403 called rl), from cpse & pvx were tested.Vitek 2 gave: from cpse : -acceptable identification to the species gemella haemolysans (85%) on cl -excellent identification to the species aerococcus viridans (97%) on rl from pvx : -acceptable identification to the species alloiococcus otitis (89%) on cl -good identification to the species aerococcus viridans (92%) on rl the customer misidentifications were duplicated in house.The species a.Sanguinicola is not included in the vitek 2 v7.01 gp card knowledge base.There is a limitation 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 GRAM POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 7215406
• MDR Text Key: 98295276
• Report Number: 1950204-2018-00043
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL. I EXEMPT
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420462203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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