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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of enterococcus faecium when testing with vitek® 2 gram positive test kit (ref 21342) as part of an external quality control (eqc).Vitek 2 identified the organism as enterococcus gallinarum twice.There is no indication or report from the laboratory that the discrepant quality result led to any adverse event related to any patient's state of health.There was no patient associated with this quality control sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a misidentification of enterococcus faecium as enterococcus gallinarum when testing with vitek® 2 gram positive test kit (ref 21342) as part of an external quality control (eqc).An internal biomérieux investigation was performed.The customer reported setting up the isolate from cpse after incubating for 24 hours.No other set up information was provided.Two (2) vitek 2 ast lab reports and one (1) vitek 2 gp lab report were submitted.The gp lab report showed an excellent identification of e.Gallinarum with two (2) atypical positive reactions (amy, dxyl) 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 misidentification.Vitek 2 gp lot # 2420374403 met final qc release criteria and passed initial qc performance testing.

• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7180321
• MDR Text Key: 96965066
• Report Number: 1950204-2018-00017
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420374403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• 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