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 Code	QJR
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	12973	13060
False Negative Result	2392	2404
Incorrect, Inadequate or Imprecise Result or Readings	2360	2378
Output Problem	2033	2033
Non Reproducible Results	1707	1707
No Apparent Adverse Event	1389	1389
Erratic Results	580	581
Nonstandard Device	109	109
Unable to Obtain Readings	100	100
Off-Label Use	68	68
Device Contaminated at the User Facility	51	51
Improper or Incorrect Procedure or Method	33	33
Use of Device Problem	25	25
Increased Sensitivity	25	25
Adverse Event Without Identified Device or Use Problem	24	25
Defective Component	14	14
Low Readings	13	13
Incorrect Measurement	12	12
Insufficient Information	11	11
Device Markings/Labelling Problem	10	19
Product Quality Problem	9	23
Contamination	8	8
Leak/Splash	7	7
Optical Obstruction	6	6
Patient-Device Incompatibility	6	7
Patient Device Interaction Problem	6	6
Contamination /Decontamination Problem	5	6
High Test Results	4	4
Device Displays Incorrect Message	4	5
Failure to Calibrate	3	3
Signal Artifact/Noise	3	3
Missing Information	3	3
Therapeutic or Diagnostic Output Failure	3	4
Fluid/Blood Leak	2	2
Erratic or Intermittent Display	2	2
Break	2	4
Temperature Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
No Device Output	2	2
Environmental Particulates	2	2
Component Missing	2	2
Unexpected Therapeutic Results	2	2
Material Separation	2	2
Ambient Temperature Problem	1	1
Defective Device	1	3
Chemical Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Device Ingredient or Reagent Problem	1	5
Difficult to Open or Close	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16224	16267
Insufficient Information	1455	1521
Anxiety	1319	1319
Unspecified Respiratory Problem	1120	1120
No Consequences Or Impact To Patient	400	400
Viral Infection	362	369
Respiratory Tract Infection	210	210
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	62	62
Sore Throat	61	63
Cough	47	50
Fever	46	48
Headache	41	44
Fatigue	32	38
Pain	15	20
Dyspnea	12	14
Burning Sensation	10	11
Malaise	8	8
Taste Disorder	6	9
Hypersensitivity/Allergic reaction	6	6
Chills	5	6
Epistaxis	4	4
Tinnitus	4	6
Alteration in Body Temperature	4	4
Nausea	4	7
Muscle Weakness	3	5
No Known Impact Or Consequence To Patient	3	3
Tachycardia	3	3
Diarrhea	3	5
No Patient Involvement	3	3
Vomiting	3	7
Sneezing	3	3
Pneumonia	3	3
Sleep Dysfunction	2	2
Dizziness	2	3
Itching Sensation	2	2
Myalgia	2	2
Blurred Vision	2	2
Skin Inflammation/ Irritation	2	2
Test Result	2	2
Distress	2	2
Emotional Changes	2	2
Apnea	2	2
Numbness	2	3
Chest Pain	2	4
Discomfort	2	2
Virus	2	2
Eye Pain	1	1
Unspecified Infection	1	1
Loss of consciousness	1	1
Hemorrhage/Bleeding	1	1