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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE (GN) TEST KIT

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BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE (GN) TEST KIT Back to Search Results
Model Number 21341
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Biomérieux conducted an internal investigation: the organism was subcultured on cba media and tested on 16s sequencing to determine the intended result. The sequencing 16s result identified acinetobacter courvalinii (99. 92%). The intended species (acinetobacter courvalinii) doesn't belong to vitek® 2 gn card knowledge base (kb). There is a limitation on vitek® 2 for species not claimed in the kb. Testing of unclaimed species may result in an unidentified result or a misidentification.
 
Event Description
A customer in (b)(6) notified biomérieux of a misidentification associated with vitek® 2 gram negative (gn) test kit. The customer reported obtaining a good identification result for acinetobacter baumanii complex (95%). The sequencing result - seq 16s was acinetobacter courvalinii (99. 82%). Acinetobacter courvalinii is not a claimed species on the vitek® 2 gp test kit, however the test identified the organism as acinetobacter baumanii complex instead of an expected no identification. The system vitek® ms gave no identification.
 
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Brand NameVITEK® 2 GRAM NEGATIVE (GN) TEST KIT
Type of DeviceVITEK® 2 GRAM NEGATIVE (GN) TEST KIT
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6530629
MDR Text Key74023105
Report Number1950204-2017-00135
Device Sequence Number1
Product Code JTO
UDI-Device Identifier03573026131913
UDI-Public03573026131913
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
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
Report Date 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/13/2017
Device Model Number21341
Device Lot Number241377310
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 Received04/03/2017
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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