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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID TEST KIT

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BIOMERIEUX INC. VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID TEST KIT 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  
Event Description
A customer from the united states reported to biomérieux a discrepant result for a urine sample in association with the vitek® 2 nh test kit. The customer initially tested the sample using the vitek® ms which identified neisseria meningitides. Confirmation testing of the isolate with vitek® 2 nh gave a result of (b)(6). A repeat test with the vitek® ms identified neisseria meningitides and pcr was (b)(6). The result of neisseria meningitides was reported to the physician. 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 did not repeat the test for vitek® 2 nh as they did not have enough isolate colonies. The customer does not have the isolate for evaluation. An internal biomérieux investigation has been initiated.
 
Manufacturer Narrative
A customer reported a misidentification of neisseria meningitidis as neisseria gonorrhoeae by the vitek® 2 nh test kit lot # 245369522 with vitek 2 7. 01 software. The identification to neisseria meningitidis was confirmed through pcr and ms. The customer did not submit strain or raw data for analysis. An investigation was conducted. The customer had set up the patient isolate from a 48-hour culture grown on chocolate agar. Use of a 48-hour culture is not recommended. The age of culture should be 18-24 hrs. A lab report was submitted that showed a very good identification of neisseria gonorrhoeae with five (5) atypical positive reactions (arga, lysa, tyra, pvate, appa), and one (1) atypical negative reaction (dmal), for an identification of neisseria meningitidis according to the vitek® 2 nh knowledge base. An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors or an atypical strain. However without the strain or raw data it's not possible to further evaluate the cause of the misidentification. A review of quality records confirmed the nh id lot 245369522 met qc criteria for initial performance testing and final release. In conclusion, the customer tested the isolate from 48-hour culture, rather than 18-24 hours as specified in the nh id product information. The customer did not submit the isolate or raw card data, therefore the misidentification could not be confirmed.
 
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Brand NameVITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 NH ID TEST KIT
Manufacturer (Section D)
BIOMERIEUX INC.
595 anglum road
hazelwood MO 63042
Manufacturer (Section G)
BIOMERIEUX INC.
595 anglum road
hazelwood MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key6177522
MDR Text Key62544356
Report Number1950204-2016-00205
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K842587
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 03/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2017
Device Catalogue Number21346
Device Lot Number245369522
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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