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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
Product CodeMDB
Regulation Number 866.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
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 586 586

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 783 783
Incorrect, Inadequate or Imprecise Result or Readings 760 760
Contamination 275 275
False Negative Result 124 124
Leak/Splash 51 51
Device Markings/Labelling Problem 51 51
Contamination of Device Ingredient or Reagent 30 30
Fluid/Blood Leak 25 25
Incorrect Or Inadequate Test Results 20 20
Break 19 19
Overheating of Device 15 15
Device Displays Incorrect Message 15 15
Unintended Movement 15 15
Missing Information 12 12
Contamination /Decontamination Problem 10 10
Microbial Contamination of Device 9 9
Crack 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Data Problem 4 4
Patient Data Problem 3 3
Missing Test Results 3 3
Failure to Obtain Sample 3 3
Date/Time-Related Software Problem 3 3
Device Damaged Prior to Use 3 3
Smoking 3 3
Device Inoperable 2 2
Device Contamination with Body Fluid 2 2
Fracture 2 2
Physical Resistance/Sticking 2 2
No Device Output 2 2
Output Problem 2 2
Device Operates Differently Than Expected 2 2
Device Ingredient or Reagent Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Communication or Transmission Problem 1 1
Difficult to Open or Close 1 1
Misassembly by Users 1 1
Positioning Problem 1 1
Pressure Problem 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
Structural Problem 1 1
Expiration Date Error 1 1
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1732 1732
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
Insufficient Information 7 7
No Information 5 5
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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