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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 GN TEST KIT

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BIOMERIEUX, INC VITEK 2 GN TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux of a misidentification associated with the vitek® 2 gn test kit. The customer reported obtaining an identification of shigella using the vitek® 2 gn test kit; however, the sample was sent to a state laboratory where no shigella was isolated. Testing was repeated using the vitek® 2 gn test kit and the same result was obtained. The customer indicated shigella results were reported to the physician. In addition, the customer indicated the sample was no longer available. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
A biomérieux internal investigation was conducted for a misidentification; however, the customer did not comply with a biomérieux request for raw data and patient isolate submittal. Information about the vitek® 2 gn card set up was not provided. One isolate was from a stool culture and the other was from sputum. It was noted that one strain was set up from macconkey agar and unknown for the other isolate. Two lab reports were submitted with both showing excellent identification of shigella sonnei. However, a reference identification was not provided, therefore no analysis of atypical reactions could be made. When a result of shigella sonnei is reported, the following message is printed on the vitek® 2 lab report: "confirm by serological tests. A review of quality control records confirmed the lot met the criteria for release and performance testing. No further investigation is possible without the raw data or isolate.
 
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Brand NameVITEK 2 GN TEST KIT
Type of DeviceVITEK 2 GN 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
st. louis, MO 63042
MDR Report Key6173806
MDR Text Key62389686
Report Number1950204-2016-00204
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 02/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2016
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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