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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, hiv detection
Product CodeMZF
Regulation Number 866.3956
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDMIRA LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 49 49
2015 74 74
2016 79 79
2017 135 135
2018 580 580
2019 154 154
2020 66 66
2021 65 65
2022 115 115
2023 88 88
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 811 811
False Negative Result 310 310
Incorrect, Inadequate or Imprecise Result or Readings 113 113
Low Test Results 57 57
Adverse Event Without Identified Device or Use Problem 44 44
High Test Results 27 27
Non Reproducible Results 19 19
Incorrect Or Inadequate Test Results 17 17
No Apparent Adverse Event 14 14
Calibration Error 13 13
Leak/Splash 11 11
Improper or Incorrect Procedure or Method 6 6
Use of Device Problem 5 5
Appropriate Term/Code Not Available 4 4
False Reading From Device Non-Compliance 2 2
Unable to Obtain Readings 2 2
Insufficient Information 2 2
Mechanical Problem 1 1
Output Problem 1 1
Wrong Label 1 1
Inadequate or Insufficient Training 1 1
Off-Label Use 1 1
Human Factors Issue 1 1
Device Operates Differently Than Expected 1 1
Illegible Information 1 1
Patient-Device Incompatibility 1 1
Low Readings 1 1
Data Problem 1 1
Failure to Calibrate 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 775 775
No Information 453 453
No Clinical Signs, Symptoms or Conditions 266 266
No Consequences Or Impact To Patient 147 147
Pregnancy 88 88
No Patient Involvement 69 69
No Code Available 29 29
HIV, Human Immunodeficiency Virus 23 23
Insufficient Information 19 19
Misdiagnosis 16 16
Test Result 10 10
Positive antinuclear antibodies (ANA) 8 8
Exposure to Body Fluids 7 7
Missing Value Reason 5 5
Cancer 5 5
Needle Stick/Puncture 4 4
Eye Injury 4 4
Anxiety 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Confusion/ Disorientation 2 2
Chemical Exposure 2 2
Hepatitis 2 2
Herpes 2 2
Death 2 2
Unspecified Infection 2 2
Inflammation 1 1
Overdose 1 1
Pain 1 1
Venereal Disease 1 1
Vomiting 1 1
Diarrhea 1 1
Emotional Changes 1 1
Bradycardia 1 1
Hypersensitivity/Allergic reaction 1 1
Hemorrhage/Bleeding 1 1
Irregular Pulse 1 1
Sleep Dysfunction 1 1
Reaction 1 1
Numbness 1 1
Viral Infection 1 1

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