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

A customer in the united states contacted biomérieux to report obtaining two different organism identifications (kocuria kristinae and kocuria rhizophila) for a single patient isolate in association with the vitek® 2 gram-positive (gp) identification (id) test kit.The isolate was tested via vitek® ms and provided a result of noid (no identification).No other method of testing was performed by the customer; the definitive organism identification is unknown.There is no indication or report from the laboratory that the inconsistent results led to any adverse event related to the patient's state of health.Though it is unknown which identification result (if either) is correct, it is concluded that at least one of them is not correct.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the united states contacted biomérieux to report a misidentification of dolosigranulum pigrum as either kocuria kristinae or kocuria rhizophila in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Investigational testing was performed using the specimen submitted by the customer.Vitek® 2 gp id (customer lot and random lot): customer lot: excellent id (99%) of kocuria rhizophila.Random lot: low discrimination call of granulicatella elegans/micrococcus.Luteus/micrococcus lylae/kocuria rhizophila.Vitek® ms: obtained no identification (noid).Api® 20 strep: very good id (99.7%) to aerococcus urinae.16s sequencing: identification of dolosigranulum pigrum.Dolosigranulum pigrum is an unclaimed species for the gp card knowledge base.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." the investigation concluded there is no evidence to suggest the vitek® 2 gp id card did not function 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: 6768856
• MDR Text Key: 83229055
• Report Number: 1950204-2017-00251
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420307103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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