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TPLC
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show TPLC since
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Device
system, blood culturing
Product Code
MDB
Regulation Number
866.2560
Device Class
1
Premarket Reviews
Manufacturer
Decision
BECTON DICKINSON
SUBSTANTIALLY EQUIVALENT
1
BECTON DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2017
121
121
2018
76
76
2019
147
147
2020
37
37
2021
1184
1184
2022
486
486
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
771
771
Incorrect, Inadequate or Imprecise Resultor Readings
723
723
Contamination
261
261
False Negative Result
116
116
Leak/Splash
49
49
Device Markings/Labelling Problem
43
43
Fluid Leak
25
25
Incorrect Or Inadequate Test Results
20
20
Break
19
19
Overheating of Device
15
15
Device Displays Incorrect Message
15
15
Contamination of Device Ingredient or Reagent
12
12
Missing Information
12
12
Unintended Movement
11
11
Contamination /Decontamination Problem
10
10
Crack
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Microbial Contamination of Device
5
5
Data Problem
4
4
Patient Data Problem
3
3
Missing Test Results
3
3
Device Damaged Prior to Use
3
3
Smoking
3
3
Failure to Obtain Sample
3
3
Date/Time-Related Software Problem
3
3
Device Inoperable
2
2
No Device Output
2
2
Device Contamination with Body Fluid
2
2
Fracture
2
2
Physical Resistance/Sticking
2
2
Device Ingredient or Reagent Problem
2
2
Device Operates Differently Than Expected
2
2
Device Contamination with Chemical or Other Material
2
2
Human-Device Interface Problem
2
2
Output Problem
2
2
Positioning Problem
1
1
Pressure Problem
1
1
Misassembly by Users
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Difficult to Open or Close
1
1
Intermittent Loss of Power
1
1
Audible Prompt/Feedback Problem
1
1
Excessive Heating
1
1
Misassembled During Installation
1
1
Fire
1
1
Off-Label Use
1
1
Unable to Obtain Readings
1
1
Mechanical Problem
1
1
Deflation Problem
1
1
Material Discolored
1
1
Component Falling
1
1
Alarm Not Visible
1
1
Use of Device Problem
1
1
Retraction Problem
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Communication or Transmission Problem
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1632
1632
No Known Impact Or Consequence To Patient
274
274
No Consequences Or Impact To Patient
145
145
No Patient Involvement
35
35
Misdiagnosis
31
31
Bacterial Infection
8
8
Death
7
7
No Information
5
5
Insufficient Information
4
4
Sepsis
4
4
Exposure to Body Fluids
3
3
Injury
3
3
Needle Stick/Puncture
3
3
Headache
2
2
Unspecified Infection
1
1
Pain
1
1
Swelling
1
1
Fungus
1
1
Patient Problem/Medical Problem
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
bioMerieux, Inc.
II
Oct-24-2018
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