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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC VITEK® 2 GN TEST KIT 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  
Event Description
A customer from the (b)(6) reported to biomérieux a misidentification of citrobacter amalonaticus as serratia odorifera, for a blood culture from a dialysis patient, in association with vitek 2 gn test kit. The technicians determined the isolate was not serratia odorifera based on culture smell, which prompted testing of the isolate with an alternative method (microscan). The result was citrobacter amalonaticus. 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. The customer sent the test reports to biomérieux and sent the isolate to an external lab for testing. A field service engineer was scheduled to visit the customer site. A biomerieux internal investigation has been initiated.
 
Manufacturer Narrative
A customer from the united states reported to biomérieux a misidentification of citrobacter amalonaticus as serratia odorifera in association with vitek® 2 gn test kit. An internal biomérieux investigation was performed. The organism was subbed and testing included both the customer lot and a random lot of vitek® 2 gn cards. Api® 20 e was performed, as was vitek® ms and 16s sequencing. On both cards tested, an excellent id (99%) of s. Odorifera was obtained. Api® 20 e gave a good identification to the genus of pantoea. Vitek® ms gave an identification of leclercia adecarboxylata (99. 9% confidence value). However, when 16s sequencing was performed, a 99% identity match to both enterobacter amnigenus and leclercia sp. Was obtained. A comparison of card reaction results for s. Odorifera against the expected reaction results for e. Amnigenus resulted in one (1) atypical positive reaction (ellm). A comparison of card reaction results for s. Odorifera against the expected reaction results for l. Adecarboxylata resulted in two (2) atypical positive reactions (dsor, cit). Conclusion: atypical strain.
 
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Brand NameVITEK® 2 GN TEST KIT
Type of DeviceVITEK® 2 GN TEST KIT
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 Key6354825
MDR Text Key68367209
Report Number1950204-2017-00067
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
C1, EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/27/2017
Device Catalogue Number21341
Device Lot Number241390940
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 Received04/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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