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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A customer in the united states reported to biomérieux a discrepant result for a blood culture isolate in association with the vitek® 2 gn test kit. The customer tested a gram negative bacilli which was identified as klebsiella oxytoca with the vitek® 2 gn test. The customer stated that their offline test for indole was negative with the klebsiella oxytoca isolate and should be positive. The isolate was cultured on macconkey blood agar. Repeat testing produced the same result. The customer sent the klebsiella oxytoca to a reference laboratory for id confirmation. The isolate was identified as klebsiella pneumoniae. The customer reported there was no impact to the patient's health or treatment. The isolate and test reports were requested from the customer. An internal biomérieux investigation has been initiated.
 
Manufacturer Narrative
Biomérieux conducted an internal investigation: the 4 organisms were subbed, and testing included the customer lot and a random lot of gn cards. Api 20 e was also performed. Isolate 911255 (k. Oxytoca): both cards gave an excellent id (98%) of k. Pneumoniae ssp pneumoniae. The api 20 e also gave a good id (97. 3%) of k. Pneumoniae ssp pneumoniae. Therefore, the final identification of this organism is k. Pneumoniae ssp pneumoniae. Isolates 911256 and 911258 (k. Pneumoniae): for both isolates, all cards tested gave an excellent id (98%) of k. Oxytoca. However, the api 20 e gave a good id (97. 3%) of k. Pneumoniae ssp pneumoniae, so the final identification of these organisms is k. Pneumoniae ssp pneumoniae. Isolate 911257 (k. Pneumoniae): both gn cards gave a very good id - slashline of e. Cloacae complex. Api 20 e also gave a good id (97. 7%) of e. Cloacae. Therefore, the final identification of this organism is e. Cloacae. A comparison of reaction results for the cards giving the misidentification of k. Oxytoca to the expected reaction results for k. Pneumoniae ssp pneumoniae revealed 1 atypical negative reaction (bxyl) and 1 atypical positive reaction (5kg) that led to the misidentification. No corrective action is warranted at this time. Biomérieux will continue to monitor for trends.
 
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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
hazelwood MO 63042
Manufacturer (Section G)
BIOMERIEUX INC.
595 anglum road
hazelwood MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key6170379
MDR Text Key62384750
Report Number1950204-2016-00202
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 02/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/26/2017
Device Catalogue Number21341
Device Lot Number241393940
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 Received01/24/2017
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 Unkown

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