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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 2014 2018

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 6953 6961
Incorrect, Inadequate or Imprecise Resultor Readings 3353 3353
Output Problem 2557 2557
Non Reproducible Results 1991 1991
False Negative Result 1430 1430
No Apparent Adverse Event 237 238
Nonstandard Device 72 72
Off-Label Use 59 59
Erratic Results 39 39
Unable to Obtain Readings 28 28
Use of Device Problem 26 26
Adverse Event Without Identified Device or Use Problem 24 24
Device Contaminated at the User Facility 23 23
Improper or Incorrect Procedure or Method 23 23
Insufficient Information 19 19
Low Readings 13 13
Application Program Problem 9 9
Device Markings/Labelling Problem 8 8
Contamination 8 8
Patient-Device Incompatibility 6 6
Optical Obstruction 6 6
Patient Device Interaction Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Product Quality Problem 4 4
No Device Output 4 4
Leak/Splash 4 4
Device Contamination with Chemical or Other Material 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Temperature Problem 2 2
Fluid Leak 2 2
Device Displays Incorrect Message 2 2
High Test Results 2 2
Low Test Results 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Defective Device 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Gas Output Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Break 1 1
Component Incompatible 1 1
Melted 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Packaging Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Ingredient or Reagent Problem 1 5
Ambient Temperature Problem 1 1
Difficult to Open or Close 1 1
Unintended Electrical Shock 1 1
Appropriate Term/Code Not Available 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8605 8617
No Consequences Or Impact To Patient 1453 1453
Anxiety 1320 1320
Unspecified Respiratory Problem 1119 1119
Insufficient Information 673 674
No Known Impact Or Consequence To Patient 240 240
Respiratory Tract Infection 201 201
Test Result 78 78
No Information 38 38
Viral Infection 22 22
Headache 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Misdiagnosis 13 13
Burning Sensation 10 10
Fever 8 8
Pain 7 7
Cough 7 7
No Patient Involvement 6 6
Fatigue 6 6
Hypersensitivity/Allergic reaction 5 5
Virus 5 5
Sore Throat 5 5
Epistaxis 4 4
Taste Disorder 4 4
Tinnitus 4 4
Malaise 4 4
Dyspnea 4 4
Vomiting 3 3
No Code Available 3 3
Numbness 2 2
Skin Inflammation/ Irritation 2 2
Blurred Vision 2 2
Pneumonia 2 2
Dizziness 2 2
Distress 2 2
Discomfort 2 2
Emotional Changes 2 2
Diarrhea 2 2
Apnea 2 2
Nausea 2 2
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Intraocular Pressure Increased 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Bronchitis 1 1
Chest Pain 1 1
Death 1 1
Dehydration 1 1
Chills 1 1
Urinary Tract Infection 1 1
Vertigo 1 1
Visual Impairment 1 1
Alteration in Body Temperature 1 1
Swelling/ Edema 1 1
Eye Pain 1 1
Spontaneous Abortion 1 1
Increased Sensitivity 1 1
Loss of consciousness 1 1
Foreign Body In Patient 1 1
Sensitivity of Teeth 1 1
Neck Pain 1 1
Low Oxygen Saturation 1 1
Paresthesia 1 1
Swollen Lymph Nodes/Glands 1 1
Wheezing 1 1

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