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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 CARD

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BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD 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
(b)(4). Biomérieux internal investigation was conducted for patient isolates received from each customer for events 1 - 5. Investigation for event #6 is pending. Events #1 & 2: in each case, a reference method identified an organism that is not claimed in the vitek® 2 gram negative knowledge base. The vitek® 2 product information manual states the following for gram-negative identification: "newly described or rare species may not be included in the gn database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification. " in addition, for event #2, the customer did not follow instructions for use with respect to culture incubation time. Event #3: the patient isolate was submitted to biomérieux and investigation was conducted. The investigation showed an inability to obtain a consistent identification result regardless the test method used: 16s sequencing, api 50che, id 32e strips, vitek ms, or vitek 2 gn id card (customer lot and random lot). The investigation concluded the patient isolate is an atypical organism for all methods tested. Event #4: the correct organism identification of citrobacter freundii was obtained via vitek® 2 gn id test kit (customer lot and random lot). The investigation did not duplicate the misidentification obtained by the customer as shigella group. Event #5: the patient isolate was sent to a reference laboratory which was unable to identify the organism via alternate rapid test method. The investigation concluded that the patient isolate is an atypical strain for vitek® 2 system phenotypic rapid ast testing method. Methods such as api® and disc diffusion are more conducive to testing organisms exhibiting slow-growth behavior. The investigations concluded the vitek® 2 gn id card is performing as intended and within the scope of product specifications.
 
Event Description
This report summarizes 6 malfunction events. A review of the events indicated that testing via the vitek® 2 gram negative (gn) identification (id) test kit resulted in organism misidentifications. Misidentification of non-salmonella isolate as salmonella. Misidentification of roseomonas rosea. Misidentification of enterobacter cloacae as serratia plymuthica. Misidentification of citrobacter freundii as shigella group. Misidentification of gram negative rod, lactose positive as pseudomonas luteola. Misidentification of citrobacter workmanii as citrobacter farmeri. All of the events involved patient organism identification test results. None of the events led to any adverse event related to a patient's state of health. Culture submittals and raw test data were requested for each event.
 
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Brand NameVITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 GN ID 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
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5595790
MDR Text Key43287649
Report Number1950204-2016-00042
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
PMA/PMN Number
CL. I EXEMPT
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 04/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21341
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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