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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, equipment, automated bloodborne pathogen
Product CodeMZA
Device Class Not Classified

MDR Year MDR Reports MDR Events
2019 30 30
2020 27 27
2021 20 20
2022 28 28
2023 10 10
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 40 40
Leak/Splash 23 23
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Thermal Decomposition of Device 8 8
Fluid/Blood Leak 7 7
False Negative Result 6 6
Device Displays Incorrect Message 5 5
Sparking 3 3
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Therapeutic or Diagnostic Output Failure 3 3
High Test Results 3 3
Display or Visual Feedback Problem 2 2
Calcified 2 2
Protective Measures Problem 2 2
Detachment of Device or Device Component 2 2
Data Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Moisture Damage 2 2
Defective Component 2 2
Output Problem 2 2
Break 2 2
Activation, Positioning or Separation Problem 2 2
Use of Device Problem 1 1
Moisture or Humidity Problem 1 1
Unintended Ejection 1 1
Sharp Edges 1 1
Misassembled During Installation 1 1
High Readings 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Installation-Related Problem 1 1
Computer Software Problem 1 1
Smoking 1 1
Device Fell 1 1
Difficult to Open or Close 1 1
Failure to Auto Stop 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
No Known Impact Or Consequence To Patient 26 26
No Consequences Or Impact To Patient 16 16
No Patient Involvement 8 8
No Code Available 4 4
Insufficient Information 3 3
Superficial (First Degree) Burn 2 2
Test Result 2 2
Chemical Exposure 2 2
Injury 2 2
Needle Stick/Puncture 2 2
Caustic/Chemical Burns 2 2
Damage to Ligament(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Exposure to Body Fluids 1 1
Laceration(s) 1 1
Eye Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Mar-11-2022
2 Abbott Laboratories, Inc II Aug-12-2021
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