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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 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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