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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of the misidentification of kocuria kristinae when testing with vitek® 2 gp id test kit (reference 21342).The strain was isolated from a positive blood culture from an icu patient's cv line.Vitek 2 identified the organism as streptococcus pneumonia (97%).The colony characteristics did not match this identification; therefore, the customer repeated the test.Vitek 2 then identified the organism as kocuria kristinae, which the customer stated matched the colony characteristics and biochemical results.No further confirmatory testing was done.The customer stated that they reported the kocuria kristinae result so no wrong results were reported to a physician.There is no indication or report from the laboratory 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 in (b)(6) notified biomérieux of the misidentification of kocuria kristinae when testing with vitek® 2 gp id test kit (reference 21342).An investigation was performed.The isolate was from a positive blood culture.Trypticase soy agar with 5% sheep blood was used and no other set up information was provided.The strain was identified as kocuria kristinae by catalase positive, pyr positive, lap positive, esc positive, oxidase positive, and staph latex negative.The colonies were white/grey, non-hemolytic and strong adherence to the agar.The strain was repeated and the identified as kocuria kristinae on the vitek 2 gp card.The customer reported the saline dispenser was cleaned with alcohol both pre and post testing.It is not recommended to clean the dispenser with alcohol which may lead to false positive reactions.Two lab reports were received.One showed a good identification of k.Kristinae.The other lab report submitted had an excellent identification of strep.Pneumoniae with six atypical positive reactions (amy, appa, bgar, bgal, dmal, mbdg) for an identification of k.Kristinae according to the gp knowledge base.Since k.Kristinae is a "sticky" colony, it's possible that during the first card set up, blood agar along with the colonies may have been picked up due to less robust organism growth.Upon re-test the plate was older and the growth may have been more robust and easier to select organisms without agar contamination.An increased number of atypical reactions can indicate contamination, user set up error, or an atypical strain.Without the strain or raw data it is not possible to further evaluate the cause of the misidentification.The vitek gp lot # 2420509103 met final qc release criteria.This lot passed 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: 7345280
• MDR Text Key: 103274967
• Report Number: 1950204-2018-00104
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/17/2018

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: 04/19/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420509103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2018
• 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