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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE ID TEST KIT

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BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE ID TEST KIT 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  
Event Description
A customer notified biomerieux that they had mis-identifications when using the vitek® 2 gram negative id test kit. A pseudomonas sample was identified by the test kit as a burkholderia. Additionally, an acinetobacter was as klebsiella oxytoca. When specifically asked the customer noted no injury or death happened as a result of the mis-identifications. An investigation will be initiated by biomerieux to investigate this event.
 
Manufacturer Narrative
This report was initially submitted following notification that a customer in canada reported occasional misidentification of gram negative rods (e. G. Pseudomonas as burkholderia or acinetobacter as klebsiella) in association with the vitek® 2 gn id test kit. Biomérieux investigation was conducted. However, no patient strains, lab reports, raw data, lot # nor software version were provided by the customer. The customer reported testing the isolates from bbl chrom agar which is a non-recommended media. Testing from a non-recommended media may cause atypical reactions according to the vitek® 2 gn id knowledge base. A complaint history review was completed for these issues during the last 13 month timeframe with no implication of a trend. The most recent quarterly trend review did not identify this complaint as a systemic quality issue. Without the patient isolate(s) or raw data, no further investigational testing is possible. There is no evidence to suggest the vitek® 2 gn id test kit is performing outside of specifications.
 
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Brand NameVITEK® 2 GRAM NEGATIVE ID TEST KIT
Type of DeviceVITEK® 2 GRAM NEGATIVE ID 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
hazelwood, MO 63042
3147317301
MDR Report Key5846485
MDR Text Key52417200
Report Number1950204-2016-00081
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
CL. I 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,Followup
Report Date 06/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2016
Device Catalogue Number21341
Device Lot Number241354540
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 Received06/09/2016
Was Device Evaluated by Manufacturer? No
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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