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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC VITEK® 2 GN TEST KIT VITEK® 2 GN TEST CARD Back to Search Results
Catalog Number 21341
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the reference method (sequencing full 16s) used to determine the intended result, gives an excellent identification to the species escherichia coli (100%). The vitek® ms v3 (knowledge base v3. 0) confirmed this result. The incriminated product, vitek®2 v7. 01 gn cards from cba and xld subcultures (customer lot 2410022403, cl & random lot 241398620, rl), gives: very good identification to the species e. Coli (95%) on the cl with cba subcultures. Excellent identification to salmonella enterica ssp arizonae (96%) on the rl from cba subcultures and on both lots tested from xld subcultures. The customer misidentification is duplicated 3/4 on gn card. According to the comparison of biochemical profiles obtained on vitek®2, the misidentification to s. Enterica ssp arizonae is due to atypical results for 2 discriminating tests between the species e. Coli and s. Enterica ssp arizonae : h2s and ellm. Root cause was identified as atypical profile on vitek®2. It should be noted that, on lab reports giving salmonella, an analysis message of "confirm by serological tests" appears.
 
Event Description
A customer from the (b)(6) reported to biomérieux a twice misidentified salmonella enterica strain as salmonella enterica spp. Arizonae for an animal fecal sample in association with the vitek® 2 gn test kit (udi (b)(4)). The customer reported testing the strain twice on vitek® 2 gn and ran purity plates prior to the second test but the results were the same. The customer stated they did not do confirmation testing, as all the positive strains are sent to the (b)(4) as is required by law. The (b)(4) confirmed the strain was not salmonella. The customer stated the vitek® 2 is up to date with maintenance and there is no issue with quality control tests. There is no indication or report 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 GN TEST KIT
Type of DeviceVITEK® 2 GN 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 Key6583177
MDR Text Key247127608
Report Number1950204-2017-00161
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
C1, EXEMPT
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 09/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/18/2017
Device Catalogue Number21341
Device Lot Number2410022403
Other Device ID Number03573026131913
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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