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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of an enterococcus faecalis internal quality control strain as enterococcus faecium, in association with the vitek® 2 gp test kit.The customer reported that repeat testing was performed using a fresh subculture suspension and two different card lots, and the result was enterococcus faecalis.The customer reported that there was no patient involvement as testing was for an internal control.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) had reported to biomérieux that they obtained an identification of enterococcus faecium when testing a quality control strain with vitek® 2 gp id test kit.This control sample has an expected id of enterococcus faecalis.The customer reported that repeat testing was performed using a fresh subculture suspension and two different card lots, and the result was the expected enterococcus faecalis.An internal biomérieux investigation was performed.The customer did not submit the strain for evaluation.The customer reported setting up the isolate from bmx columbia sheep blood agar and incubating at 37c in co2.The customer noted that they thought the mis-identification was due to testing an older strain since their repeat testing with a fresh strain gave correct results.This isolate is a strain the customer uses for internal quality control but is not a package insert qc strain for the vitek® 2 gp card.Three lab reports were submitted.One with a good identification of e.Faecium.There were 5 atypical negative reactions (leua, alaa, cdex, tyra, aspa) for an identification of e.Faecalis according to the gp knowledge base.The remaining two lab reports both showed excellent identifications of e.Faecalis.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data, it's not possible to further evaluate the cause of the mis-identification.Gp lot# 2420372103 met final qc release criteria.This lot passed 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: 6836457
• MDR Text Key: 85785990
• Report Number: 1950204-2017-00289
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420372103
• 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
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2017
• 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