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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagents, 2019-novel coronavirus nucleic acid
Definition Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.
Product CodeQJR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 1636 1637
2021 7309 7317
2022 6996 7000

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 10146 10154
Incorrect, Inadequate or Imprecise Result or Readings 3471 3471
Output Problem 2578 2578
False Negative Result 2187 2187
Non Reproducible Results 2160 2160
No Apparent Adverse Event 1277 1278
Erratic Results 524 524
Nonstandard Device 106 106
Unable to Obtain Readings 69 69
Off-Label Use 67 67
Device Contaminated at the User Facility 51 51
Improper or Incorrect Procedure or Method 36 36
Adverse Event Without Identified Device or Use Problem 29 29
Use of Device Problem 26 26
Insufficient Information 21 21
Defective Component 13 13
Low Readings 13 13
Incorrect Measurement 11 11
Device Markings/Labelling Problem 10 10
Application Program Problem 9 9
Contamination 8 8
Product Quality Problem 7 7
Patient-Device Incompatibility 6 6
Optical Obstruction 6 6
Patient Device Interaction Problem 5 5
Leak/Splash 4 4
High Test Results 4 4
Contamination /Decontamination Problem 4 4
No Device Output 4 4
Therapeutic or Diagnostic Output Failure 4 4
Fluid/Blood Leak 3 3
Failure to Calibrate 3 3
Device Displays Incorrect Message 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Missing Information 3 3
Unexpected Therapeutic Results 3 3
Component Missing 2 2
Temperature Problem 2 2
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1
Microbial Contamination of Device 1 1
Structural Problem 1 1
Defective Device 1 1
Difficult to Open or Close 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Gas Output Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Overheating of Device 1 1
Melted 1 1
Erratic or Intermittent Display 1 1
Inadequacy of Device Shape and/or Size 1 1
Ambient Temperature Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Ingredient or Reagent Problem 1 5
Energy Output Problem 1 1
Peeled/Delaminated 1 1
Device Contamination with Body Fluid 1 1
Low Test Results 1 1
Unintended Electrical Shock 1 1
Material Separation 1 1
Expiration Date Error 1 1
Component Incompatible 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13202 13214
No Consequences Or Impact To Patient 1453 1453
Anxiety 1321 1321
Unspecified Respiratory Problem 1122 1122
Insufficient Information 911 912
No Known Impact Or Consequence To Patient 240 240
Respiratory Tract Infection 202 202
Viral Infection 145 145
Test Result 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 45 45
No Information 38 38
Headache 20 20
Misdiagnosis 13 13
Burning Sensation 11 11
Fever 10 10
Fatigue 9 9
Cough 8 8
Sore Throat 8 8
Pain 8 8
No Patient Involvement 6 6
Dyspnea 6 6
Hypersensitivity/Allergic reaction 5 5
Malaise 5 5
Virus 5 5
Tinnitus 4 4
Taste Disorder 4 4
Epistaxis 4 4
No Code Available 3 3
Nausea 3 3
Vomiting 3 3
Itching Sensation 2 2
Pneumonia 2 2
Diarrhea 2 2
Dizziness 2 2
Distress 2 2
Discomfort 2 2
Emotional Changes 2 2
Muscle Weakness 2 2
Numbness 2 2
Skin Inflammation/ Irritation 2 2
Blurred Vision 2 2
Apnea 2 2
Bronchitis 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Intraocular Pressure Increased 1 1
Visual Impairment 1 1
Urinary Tract Infection 1 1
Swelling/ Edema 1 1
Foreign Body In Patient 1 1
Wheezing 1 1
Increased Sensitivity 1 1
Chills 1 1
Dehydration 1 1
Loss of consciousness 1 1
Sensitivity of Teeth 1 1
Low Oxygen Saturation 1 1
Inflammation 1 1
Vertigo 1 1
Neck Pain 1 1
Cognitive Changes 1 1
Sneezing 1 1
Rash 1 1
Paresthesia 1 1
Swollen Lymph Nodes/Glands 1 1
Unspecified Eye / Vision Problem 1 1
Spontaneous Abortion 1 1
Depression 1 1
Chest Pain 1 1
Unspecified Infection 1 1
Eye Pain 1 1
Alteration in Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Dec-20-2022
2 Abbott Molecular, Inc. II Sep-06-2022
3 Abbott Molecular, Inc. I Oct-14-2021
4 Becton Dickinson & Co. II Apr-13-2021
5 Becton Dickinson & Co. II Feb-05-2021
6 Becton Dickinson & Co. II Aug-04-2020
7 Biomeme, Inc. II Jan-04-2022
8 Biomeme, Inc. III Feb-01-2021
9 Biomeme, Inc. II Dec-01-2020
10 DNA Genotek Inc. II Apr-21-2022
11 DiaSorin Molecular LLC II Oct-21-2021
12 GS Biomark LLC II Nov-29-2022
13 Life Technologies Corporation II Sep-17-2020
14 Luminex Corporation II Oct-26-2022
15 Luminex Corporation II Aug-17-2022
16 MESA BIOTECH, INC I May-06-2022
17 Meridian Bioscience Inc II Jan-20-2023
18 Meridian Bioscience Inc II May-07-2021
19 NeuMoDx Molecular Inc II Apr-22-2022
20 NeuMoDx Molecular Inc II Mar-08-2022
21 NeuMoDx Molecular Inc II Jun-29-2021
22 OPTI Medical Systems, Inc II Aug-17-2021
23 Quidel Corporation II Sep-15-2021
24 Quidel Corporation I Jun-26-2021
25 Roche Molecular Systems, Inc. II Apr-13-2021
26 VISBY MEDICAL INC II Jan-12-2021
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