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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer from the united states reported to biomérieux a misidentification of an escherichia coli urine sample as shigella sonnei in association with the vitek® 2 gn test kit. The customer reported the isolate was tested four (4) times with vitek® 2 gn and received an identification of shigella sonnei. The isolate was sent to a state laboratory for serology testing (maldi-tof) and the isolate was determined to be escherichia coli. There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health. The test reports were requested from the customer. An internal biomérieux investigation has been initiated.
 
Manufacturer Narrative
A customer from the united states reported to biomérieux a misidentification of an escherichia coli urine sample as shigella sonnei in association with the vitek® 2 gn test kit. An internal biomérieux investigation was performed. Testing included both a customer lot and a random lot of vitek® 2 gn cards. Api® 20 e was also performed. All cards tested gave an excellent id (99%) of s. Sonnei. Api® 20 e, however, gave a good identification (92. 3%) of e. Coli. A comparison of expected reaction results for e. Coli resulted in three (3) atypical negative reactions (dsor, phos, ldc), which led to the misidentification. It should be noted that, when an identification of shigella is made by vitek® 2 gn cards, an analysis message of "confirm by serological tests" is given. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend. Root cause: atypical strain.
 
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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 Key6385695
MDR Text Key69330703
Report Number1950204-2017-00081
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
C1, 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 04/18/2017
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 Date07/25/2017
Device Catalogue Number21341
Device Lot Number241387640
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 Manufactured07/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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