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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, blood culturing
Regulation Description Microbial growth monitor.
Product CodeMDB
Regulation Number 866.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
BECTON DICKINSON
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 291 291
2017 121 121
2018 76 76
2019 147 147
2020 37 37
2021 789 789

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 885 885
False Positive Result 405 405
Contamination 197 197
False Negative Result 79 79
Leak/Splash 28 28
Device Markings/Labelling Problem 27 27
Incorrect Or Inadequate Test Results 21 21
Fluid Leak 17 17
Overheating of Device 15 15
Device Operates Differently Than Expected 15 15
Device Displays Incorrect Message 15 15
Break 11 11
Contamination /Decontamination Problem 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Crack 5 5
Microbial Contamination of Device 5 5
Date/Time-Related Software Problem 4 4
Missing Information 4 4
Unintended Movement 4 4
Data Problem 4 4
Contamination of Device Ingredient or Reagent 3 3
Device Damaged Prior to Use 3 3
Missing Test Results 3 3
Fracture 3 3
Smoking 3 3
No Device Output 2 2
Human-Device Interface Problem 2 2
Output Problem 2 2
Device Contamination with Body Fluid 2 2
Failure to Obtain Sample 2 2
Device Inoperable 2 2
Device Ingredient or Reagent Problem 2 2
Physical Resistance/Sticking 2 2
Audible Prompt/Feedback Problem 1 1
Excessive Heating 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Loss of Data 1 1
Unable to Obtain Readings 1 1
Material Discolored 1 1
Alarm Not Visible 1 1
Component Falling 1 1
Misassembly by Users 1 1
Patient Data Problem 1 1
Intermittent Loss of Power 1 1
Misassembled During Installation 1 1
Defective Device 1 1
Communication or Transmission Problem 1 1
Component Missing 1 1
Difficult to Open or Close 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Retraction Problem 1 1
Mechanical Problem 1 1
Fire 1 1
Deflation Problem 1 1
Use of Incorrect Control Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 754 754
No Consequences Or Impact To Patient 397 397
No Known Impact Or Consequence To Patient 305 305
Misdiagnosis 38 38
No Patient Involvement 36 36
Death 7 7
Bacterial Infection 6 6
No Information 5 5
Injury 4 4
Sepsis 4 4
Insufficient Information 4 4
Needle Stick/Puncture 3 3
Exposure to Body Fluids 3 3
Headache 2 2
Unspecified Infection 1 1
Pain 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1
Swelling 1 1
Fungus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Oct-24-2018
2 bioMerieux, Inc. II Feb-04-2016
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