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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC VITEK® 2 NH TEST KIT VITEK® 2 NH TEST CARD Back to Search Results
Catalog Number 21346
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A customer from (b)(6) notified biomerieux of a misidentification of (b)(6) as kingella denitrificans in association with the vitek® 2 nh test kit. An investigation was performed. The reference method (sequencing full 16s) was used to determine the intended result, and gave an excellent identification to the species (b)(6). Vitek® 2 nh cards were tested from the customer lot (cl : 2450075203) and a random lot (rl : 2450061203). Both lots gave an excellent identification to the species (b)(6). The misidentification to kingella denitrificans was not duplicated. A review of the customer's kingella denitrificans data against expected reactions for (b)(6) demonstrated 2 atypical (b)(6) reactions (arga and tyra) and 1 atypical (b)(6) reaction (ellm) according to the nh knowledge base, contributing to the misidentification. An increased number of atypical results can indicate a strain with decreased viability, user set up error or an atypical strain. The increased number of atypical negative reactions may have been caused by leaving the isolate out of co2 for an extended period of time. Since (b)(6) is a fastidious species, it needs to be contained in a co2 environment to retain robustness. If this species is left out on the bench outside of co2 for extended periods, it will become less robust and therefore less reactive in the nh card. The investigation concluded the vitek® 2 nh test kit performed as intended and no further action is required.
 
Event Description
A customer from (b)(6) notified biomerieux of a misidentification of neisseria gonorrhoeae as kingella denitrificans, when testing a vaginal sample in association with the vitek® 2 nh test kit (udi (b)(4)). The customer reported the isolate was cultured on pvx (polyvitex) media and incubated for 48 hours at 37°c. It was then tested with vitek® 2 nh and the result was kingella denitrificans (99%). The customer stated the strain grew on vcat3 (chocolate agar polyvitex) media and was oxidase positive. The isolate was then tested with an api® nh test strip and the identification was neisseria gonorrhoeae (98. 5%). The customer retested with a subculture after 48 hour incubation and the vitek® 2 nh identified neisseria gonorrhoeae. 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.
 
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Brand NameVITEK® 2 NH TEST KIT
Type of DeviceVITEK® 2 NH 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 Key6526229
MDR Text Key195993525
Report Number1950204-2017-00131
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K842587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/09/2018
Device Catalogue Number21346
Device Lot Number2450075203
Other Device ID Number03573026144357
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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