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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT

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BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in the united states contacted biomérieux to report a misidentification of raoultella ornithinolytica as raoultella planticola in association with the vitek® 2 gram-negative (gn) identification (id) test kit. The vitek® ms obtained the result of raoultella ornithinolytica. The customer indicates that the discrepant result did not lead to any adverse event related to any patient's state of health. Culture submittal has been requested by biomérieux for internal investigation. Biomérieux investigation will be initiated.
 
Manufacturer Narrative
A customer in the united states contacted biomérieux to report a misidentification of raoultella ornithinolytica as raoultella planticola in association with the vitek® 2 gram-negative (gn) identification (id) test kit. An internal biomérieux investigation was performed. The organism was subcultured on cba media and tested on 16s sequencing, vitek® ms, on vitek® 2, api® 50che and id32e strips. Sequencing 16s: identification to raoultella ornithinolytica 100% - intended result. Vitek® ms (v2 and v3) gave a correct identification to raoultella ornithinolytica 99. 9%; therefore, the customer result was duplicated. Testing included the vitek® 2 gn card, which resulted in an excellent identification to raoultella planticola. ; customer result duplicated. After comparison of profiles between r. Planticola and r. Ornithinolytica, the odc test (a discriminant test between these 2 species) was seen, which obtained negative leading to the misidentification of r. Ornithinolytica. Therefore, the strain has an atypical biochemical profile. Odc is also negative on api50che and id32e strips. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.
 
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Brand NameVITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 GN ID 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
hazelwood, MO 63042
3147317301
MDR Report Key6376972
MDR Text Key69110383
Report Number1950204-2017-00079
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
CL. I 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 04/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/24/2017
Device Catalogue Number21341
Device Lot Number241384540
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 Received03/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2016
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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