MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT

Catalog Number 21341

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of raoultella ornithinolytica as raoultella planticola in association with the vitek® 2 gram-negative (gn) identification (id) test kit. The vitek® ms obtained the result of raoultella ornithinolytica. The customer indicates that the discrepant result did not lead to any adverse event related to any patient's state of health. Culture submittal has been requested by biomérieux for internal investigation. Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states contacted biomérieux to report a misidentification of raoultella ornithinolytica as raoultella planticola in association with the vitek® 2 gram-negative (gn) identification (id) test kit. An internal biomérieux investigation was performed. The organism was subcultured on cba media and tested on 16s sequencing, vitek® ms, on vitek® 2, api® 50che and id32e strips. Sequencing 16s: identification to raoultella ornithinolytica 100% - intended result. Vitek® ms (v2 and v3) gave a correct identification to raoultella ornithinolytica 99. 9%; therefore, the customer result was duplicated. Testing included the vitek® 2 gn card, which resulted in an excellent identification to raoultella planticola. ; customer result duplicated. After comparison of profiles between r. Planticola and r. Ornithinolytica, the odc test (a discriminant test between these 2 species) was seen, which obtained negative leading to the misidentification of r. Ornithinolytica. Therefore, the strain has an atypical biochemical profile. Odc is also negative on api50che and id32e strips. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN ID TEST KIT
• 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: 6376972
• Report Number: 1950204-2017-00079
• Device Sequence Number: 1
• Product Code: JTO
• 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

• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/24/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241384540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial