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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE (GN) TEST KIT

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BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE (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 in (b)(6) notified biomérieux of a discrepant result associated with vitek® 2 gram negative (gn) test kit. As part of (b)(6), the customer reported the vitek® 2 gn card identified a strain as myroides instead of bergeyella zoohelcum. The customer obtained results of myroides at 98%, however, the expected result is bergeyella zoohelcum. Bergeyella zoohelcum is not part of the database for the anc cards. There is a limitation statement in the product information manual that states: "newly described or rare species may not be included in the gn database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification". However, the vitek 2 obtained an incorrect identification of myroides at 98%. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
An internal biomérieux investigation was performed. The investigation was initiated due to a misidentification of bergeyella zoohelcum on eeq survey (ctcb survey qc strain ctcb 164-1642), as myroides spp. Ctcb information: identification to the species for 63. 4% of participants and to the genus for 64. 4%. The isolate was subcultured on columbia blood agar medium, and testing included vitek® 2 gn cards from the customer lot (cl:241389540) & random lot (rl: 241379810). The results were compared with sequencing full 16s used to determine the intended result. The reference method confirmed the identification to the species bergeyella zoohelcum. On vitek® 2, multiple lots of gn cards gave a low discrimination call of myroides spp/ brevundimonas diminuta/vesicularis. The misidentification to the species myroides spp obtained by the customer (low discrimination in house) was not reproduced. Bergeyella zoohelcum is not in the vitek® 2 knowledge base (kb) and there is a limitation for species not claimed in the kb: testing of unclaimed species may result in an unidentified result or a misidentification.
 
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Brand NameVITEK® 2 GRAM NEGATIVE (GN) TEST KIT
Type of DeviceVITEK® 2 GRAM NEGATIVE (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 Key6367645
MDR Text Key68610926
Report Number1950204-2017-00075
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
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 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2017
Device Catalogue Number21341
Device Lot Number241388140
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 Received03/28/2017
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 Initial

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