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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 Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer from (b)(6) notified biomérieux of a misidentification for a begeyella zoohelcum external quality control sample (ctcb 164-2), as myroides or brevundimonas, in association with the vitek® 2 gn test kit. The expected result was begeyella zoohelcum, however, the initial and repeat test results were myroides and brevundimonas, respectively. The sample was cultured on cos and gts media. The test reports were requested from the customer. A biomérieux internal investigation will be initiated.
 
Manufacturer Narrative
An internal biomérieux investigation was performed. The investigation was initiated due to a misidentification of bergeyella zoohelcum on (b)(4) survey ((b)(4)), as myroides spp. (b)(4) 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 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 Key6383796
MDR Text Key69276328
Report Number1950204-2017-00080
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
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 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2017
Device Catalogue Number21341
Device Lot Number241391440
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
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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