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

Catalog Number 21341

Device Problem Incorrect, Inadequate or Imprecise Resultor 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 biomerieux to report a misidentification of escherichia coli as acinetobacter or aeromonas in association with the vitek 2 gn id test kit. The patient isolate was tested via vitek ms system providing a result of escherichia coli. Per laboratory guidelines, an indole test was performed; the indole test was negative so the customer tested further with the vitek 2 gn id test. The vitek 2 gn id card provided a result of acinetobacter haemolyticus. Upon investigation the laboratory technician re-subcultured the organism and re-identified via vitek 2 gn id card; the subsequent result was aeromonas sobria. The identification and ast results of aeromonas sobria were accepted and reported to physician's office. The next day the aeromonas identification was questioned. Plates were pulled and indole testing was repeated; the result was positive. The vitek ms testing was also repeated and again obtained an organism id of escherichia coli. The patient record was updated with the new results. There is no report from the hospital or treating physician that the occurrence lead to any adverse event related to the patient's state of health. Culture submittals were requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted due to vitek 2 gn id misidentification of escherichia coli as acinetobacter or aeromonas. Biomérieux investigation was conducted following receipt of the patient isolate submitted by the customer. The isolate was subcultured and testing included two (2) gn id cards from the same lot tested by the customer, two (2) gn id cards from a random lot, the api 20e, and 16s sequencing. The two gn cards from the random lot and one card from the customer lot gave low discrimination calls of escherichia coli/aeromonas sobria. The second gn card from the customer lot gave a good identification of escherichia coli. The api 20e gave a low discrimination identification of escherichia coli/citrobacter koseri/farmerii. The 16s sequencing identified the isolate as escherichia coli. Review of the customer's aeromonas sobria data against expected reactions for escherichia coli demonstrated seven atypical negative reactions as well as one atypical positive reaction, contributing to the misidentification. The investigation concluded this is an atypical strain for the vitek 2 gn knowledge base.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN 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: 5865447
• MDR Text Key: 51937726
• Report Number: 1950204-2016-00092
• 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: 07/13/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/25/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241378540
• 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: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial