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 Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of enterobacter species as klebsiella oxytoca in association with the vitek® 2 gram-negative (gn) identification (id) test kit. The customer tested three times from the same blood specimen on three different days ((b)(6) 2017) and received the same identification to klebsiella oxytoca. Following the third result of klebsiella oxytoca, the customer determined to test the isolate via malditof and via separate vitek® 2 compact. Malditof identified the isolate as enterobacter kobei. Vitek® 2 compact identified the isolate as enterobacter cloacae complex. During troubleshooting it was determined the customer does not perform routine densichek¿ maintenance, as indicated in the instructions for use (ifu). In addition, all card cassettes are configured simultaneously before introducing them to the instrument; the associated ifu indicate the cards must be placed into the instrument for processing without delay. The local field service engineer (fse) was dispatched to visit the customer site in order to confirm/perform system maintenance/repair as appropriate. The fse did not identify any system issues that may have led to the discrepant organism identification. Follow-up testing of the patient isolate obtained the expected enterobacter result using both vitek® 2 compact systems. The customer stated the klebsiella oxytoca result was reported to the treating physician. However, 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 has been initiated.

Manufacturer Narrative

A customer in (b)(6) obtained misidentifications of an e. Cloacae complex on the vitek 2 gn cards ((b)(4)). An internal biomérieux investigation was performed. The submitted isolate was subcultured and testing included vitek® 2 gn cards from the customer's lot and a random lot, in duplicate, vitek® ms and the api® 20e test kit. All four (4) vitek® 2 gn cards tested resulted in excellent slashline identifications of e. Cloacae complex (including e. Kobei). The vitek® ms gave a low discrimination identification of e. Cloacae/e. Asburiae, and the api® 20e resulted in an acceptable identification ((b)(4)) to the genus of e. Cloacae/e. Asburiae. E. Kobei is not in the vitek® ms v2 or api® 20e database. The customer's misidentification was not duplicated. Vitek® 2 gn cards are performing as expected. Review of the k. Oxytoca data, obtained after analysis times of only two (2) hours, against the expected reactions for e. Kobei, demonstrated three (3) atypical positive reactions (ado, iarl and dtag) contributing to the misidentification. An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media, user set up errors, or an atypical strain.

• 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: 6460284
• MDR Text Key: 72102857
• Report Number: 1950204-2017-00111
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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

• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/23/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241396640
• Other Device ID Number: 03573026131913
• 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: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial