MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) contacted biomérieux to report the occurrence of misidentification of listeria monocytogenes atcc 19111 and nctc 7973 in association with the vitek® 2 gp id test kit.Though not qc strains recommended by biomérieux, the customer has internal requirements to test atcc 19111 and nctc 7973 strains.The customer cultivates the strains, into fraser-broth (enrichment) or uvm main-enrichment broth and perform sub-culture on hand-made tsab or horse blood agar, incubate for 24 hours at 35-37°c with co2.This hand-made media is neither recommended nor validated for use by biomérieux, constituting off-label use by the customer.Follow-up testing by the customer using approved tsab media obtained a result of listeria innocua.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the qc strains.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation has been initiated.

Manufacturer Narrative

A customer from (b)(6) contacted biomérieux to report the occurrence of misidentification of listeria monocytogenes atcc 19111 and nctc 7973 in association with the vitek® 2 gp id test kit.An investigation was performed.The intended identification to listeria monocytogenes was confirmed on vitek ms v3 (knowledge base v3.0) for both strains.On vitek 2 (v7.01) gp cards, one card of the customer lot (2420573103), one card of customer lot (2420457403) and one card of a random lot (2420571103) were tested from tsab subculture.These tests gave an excellent identification to l.Monocytogenes (99%) whatever the lots and the strain tested.The customer misidentification was not duplicated in-house.The only difference observed between biomerieux and customer results is the piplc test result (= discriminant test) that was negative on the vitek 2 customer results, which could explain the misidentification.The vitek 2 gp card performed as intended in house and no further action is required.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7346558
• MDR Text Key: 103162376
• Report Number: 1950204-2018-00106
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CL. I 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420573103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• 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