MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID TEST KIT

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) notified biomérieux of misidentification results for two patient isolates of enterococcus faecium when testing with the vitek® 2 gp id test kit (ref 21342).Vitek 2 identified the organism as enterococcus gallinarum.However, the organism had grown on chromid® vre media with purple color.When tested with vitek ms, the customer obtained an identification of enterococcus faecium.The customer states that the final identification of the organisms is enterococcus faecium.The customer reported that there was no incorrect treatment provided nor any patient injury or harm due to this discrepant result.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) notified biomérieux of misidentification results for two (2) patient isolates of enterococcus faecium when testing with the vitek® 2 gp id test kit (ref 21342).An internal biomérieux investigation was performed.Two (2) gram positive isolates were submitted for vitek 2 evaluation because the vitek 2 gp card identified both as enterococcus gallinarum; however, vitek® ms identified both as enterococcus faecium.The misidentification was obtained on two (2) vitek 2 gp card lots (2420464203 and 2420476103).The organisms were subbed, and testing included both of the two (2) customer card lots and a random lot of vitek 2 gp card lots, run in duplicate.Vitek ms was also performed.Isolate 911611 (3028): all gp cards tested gave an acceptable id (85%) of e.Faecium.Vitek ms also gave an identification of e.Faecium, with a 99.9% confidence level.Isolate 911612 (4683): four (4) vitek 2 gp cards tested gave a low discrimination of e.Durans/ e.Faecium.Two (2) vitek 2 gp cards gave a good id (89%) of e.Faecium.Vitek ms gave an identification of e.Faecium, with a 99.9% confidence level.Since e.Faecium is given as a possible identification on the four (4) cards with the low discrimination call, and the remaining two (2) cards gave an identification of e.Faecium, vitek 2 gp card and vitek ms results are in agreement.A comparison of the customer's card reaction results for e.Gallinarum against expected reaction results for e.Faecium showed two (2) atypical positive reactions (draf, bgurr) that led to the incorrect call.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.Vitek 2 gp cards are performing as expected and no further action is necessary.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Type of Device: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7479904
• MDR Text Key: 107463950
• Report Number: 1950204-2018-00169
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420464203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2017
• 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