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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  
Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the organism was subbed and testing included both the customer lot and a random lot of gn cards. Api 20 e was also performed. On all cards tested, a slashline id of shigella group was obtained. Api 20 e, however, identified the organism as e. Coli (99. 8%). Therefore, the final identification is e. Coli. It should be noted that, on laboratory reports giving either shigella or salmonella, an analysis message of "confirm by serological tests" appears. A comparison of card reaction results for salmonella against expected reaction results for e. Coli revealed five (5) atypical negative reactions (bgal, suct, phos, glya, bgur) which led to the misidentification. A comparison of card reaction results for shigella group against expected reaction results for e. Coli revealed six (6) atypical negative reactions (bgal, dmal, suct, phos, glya, bgur) which led to the misidentification. This is an atypical strain.
 
Event Description
A customer in (b)(6) notified biomérieux of discrepant results associated with vitek® 2 gn test kit (reference 21341) related to misidentification of an organism. The customer reported results from a urine isolate. The organism grew from a pure urine culture at 35 degrees in non-co2 incubator. It was a non-lactose fermenting organism and the vitek® id card identified the organism as salmonella both times. The serology for salmonella was negative and the customer sent the organism to their reference laboratory which identified the organism as e. Coli. The "maldit" of identification was also e. Coli and simple tests showed the following reactions: indole +/-, lactose negative, tsi
=
a/a no h2s. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. There was a delay in the final report until confirmation identification was received from bccdc. An internal biomérieux investigation will be initiated.
 
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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
saint louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6441987
MDR Text Key202002767
Report Number1950204-2017-00100
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
CL 1 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 07/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2017
Device Catalogue Number21341
Device Lot Number241396710
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 Received06/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2016
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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