MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GP TEST KIT; VITEK® 2 GP TEST CARD

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 from (b)(6) reported to biomérieux a misidentification of a enterococcus faecium stool specimen from an outpatient, as enterococcus casseliflavus in association with the vitek® 2 gp test kit (udi 03573026131920).The customer first tested the isolate with vitek® 2 gp and the identification was enterococcus casseliflavus.The test was repeated using microscan and the result was enterococcus faecium.Biomérieux suggested the customer subculture the organism to tsab medium and repeat testing with vitek® 2 gp.The customer retested the gp id and sensitivity cards.The identification was enterococcus faecium (87%), and the sensitivity card terminated as the organism did not grow well.A repeat test was completed after 24 hours and the result was enterococcus gallinarum (85%) and the sensitivity card worked.The customer reported that incorrect results were not reported to the physician and there was no impact to patient results or treatment.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: the isolate was not submitted for testing therefore the customer's complaint could not be confirmed.The customer grew the strain on blood agar from bd and incubated in 5-6% co2.Age of isolate when tested was not available.The customer tested the strain three (3) times and obtained the following identifications from the gp card.Test 1: an excellent identification of e.Casseliflavus was obtained in 3.5 hrs.There were three (3) atypical positive reactions (bgar, dsor, draf) for an identification of e.Faecium according to the gp knowledge base.Test 2: an acceptable identification of e.Faecium was obtained in 4.75 hrs.There were three (3) atypical positive reactions (bgar, dsor, draf) for an identification of e.Faecium according to the gp knowledge base.However there was an additional positive reaction (nc6.5) which made the reactions match e.Faecium more favorably.Test 3: an acceptable identification of e.Gallinarum was obtained in 7 hrs.There were seven (7) atypical positive reactions (dxyl, bgar, leua, alaa, dsor, llatk, draf) for an identification of e.Faecium according to the gp knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain.However without the strain or raw data it's not possible to further evaluate the cause of the mis-identification.On 24may2017 ind- gp lot# 2420220203 met final qc release criteria.There were no issues on the initial qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6526813
• MDR Text Key: 74022855
• Report Number: 1950204-2017-00133
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420220203
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2017
• 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