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

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) customer reported misidentifications for three (3) different patient isolates in association with the vitek® 2 gp test kit ( lot 2420509103).The customer stated that for the three (3) isolates, the identification was enterococcus faecium (93%) with the gp card, and enteroccocus faecalis when testing with vitek® ms.The customer stated the media used was cos, and the quality and purity controls conformed.There was a delay greater than 24 hours for reporting results.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported misidentifications of enterococcus faecalis as enterococcus faecium for three (3) different patient isolates in association with the vitek® 2 gp test kit ( lot 2420509103).An investigation was performed.The customer reported setting up the strains from 18-24 hour cultures that were grown on cos media.Patient 1: two (2) lab reports were submitted with both showing very good identifications of e.Faecium.One lab report had four (4) atypical negative reactions (leua, tyra, aspa, aglu) and the other lab report had five (5) atypical negative reactions (leua, tyra, aspa, aglu, novo) for an identification of e.Faecalis according to the gp knowledge base.Patient 2: one (1) lab report was submitted showing a very good identification of e.Faecium with one (1) atypical negative reaction (leua) for an identification of e.Faecalis according to the gp knowledge base.Patient 3: one (1) lab report was submitted showing a very good identification of e.Faecium with three (3) atypical negative reactions (leua, aspa, aglu) for an identification of e.Faecalis according to the gp knowledge base.A second lab report was submitted showing a low discrimination call between e.Faecium and e.Faecalis.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The three (3) strains were submitted by the customer for evaluation.The second strain (s2) was contaminated by mold.Tests were conducted only with s1 and s3.The intended identification to e.Faecalis was confirmed on vitek ms v3 (knowledge base v3.0).On vitek 2 (v7.01), one (1) gp card of the customer lot (cl : 2420509103) and one (1) gp card of a random lot (rl : 2420490403) were tested from cba subculture.These tests gave an excellent identification to e.Faecalis 99% with both strains and both lots.The customer misidentification to e.Faecium was not reproduced in-house whatever the lot tested.The vitek 2 gp card performed as intended and no further action is required.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7234374
• MDR Text Key: 99222342
• Report Number: 1950204-2018-00053
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420509103
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2017
• 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