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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 Resultor 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 a non-salmonella organism as salmonella in association with the vitek® 2 gram-negative (gn) identification (id) test kit. The salmonella result was reported to the physician as presumptive. Upon receipt of a salmonella organism identification, the customer sent the isolate to the state lab for confirmatory testing. The state lab returned a response of "not salmonella. " the customer repeated the testing via vitek® 2 gn id, and obtained a result of escherichia coli. The customer stated the discrepant result did not impact patient therapy; there was no adverse impact to the patient's state of health. Culture submittal may be 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 a non-salmonella organism as salmonella in association with the vitek® 2 gram-negative (gn) identification (id) test kit. An internal biomérieux investigation was performed. The submitted isolate was subcultured and testing included vitek® 2 gn cards from the customer's lot and a random lot, in duplicate, and the api® 20e test kit. All four (4) cards tested resulted in very good identifications of escherichia coli. The api® kit resulted in an excellent identification of escherichia coli ((b)(4)). The customer's biochemical reactions for the salmonella spp. Identification are not available for review. It should be noted, when an identification of salmonella is made by vitek® 2 gn cards, an analysis message of "confirm by serological tests" is given. Vitek® 2 gn cards are performing as expected.
 
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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 Key6363841
MDR Text Key68535754
Report Number1950204-2017-00073
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 Received02/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/26/2017
Device Catalogue Number21341
Device Lot Number2410000203
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 Manufactured11/26/2016
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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