TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	1777	1777
Incorrect, Inadequate or Imprecise Result or Readings	1003	1003
Contamination	232	232
False Negative Result	221	221
Device Markings/Labelling Problem	111	111
Leak/Splash	78	78
Cross Reactivity	57	57
Contamination of Device Ingredient or Reagent	48	48
Microbial Contamination of Device	26	26
Fluid/Blood Leak	22	22
Missing Information	19	19
Unintended Movement	18	18
Break	16	16
Device Contamination with Chemical or Other Material	13	13
Contamination /Decontamination Problem	12	12
Crack	6	6
Fire	5	5
Data Problem	4	4
Device Ingredient or Reagent Problem	3	3
Communication or Transmission Problem	3	3
Inaccurate Information	3	3
Failure to Obtain Sample	3	3
Missing Test Results	3	3
Patient Data Problem	3	3
Human-Device Interface Problem	2	2
Product Quality Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Patient-Device Incompatibility	2	2
Physical Resistance/Sticking	2	2
Device-Device Incompatibility	2	2
Positioning Problem	1	1
Material Integrity Problem	1	1
Alarm Not Visible	1	1
Deflation Problem	1	1
Misassembled During Installation	1	1
Unable to Obtain Readings	1	1
Material Discolored	1	1
Failure to Power Up	1	1
Structural Problem	1	1
Expiration Date Error	1	1
Audible Prompt/Feedback Problem	1	1
Misassembly by Users	1	1
Defective Component	1	1
Smoking	1	1
Unintended Electrical Shock	1	1
Retraction Problem	1	1
Device Damaged Prior to Use	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3351	3351
No Consequences Or Impact To Patient	134	134
No Known Impact Or Consequence To Patient	132	132
Insufficient Information	36	36
Misdiagnosis	19	19
No Patient Involvement	16	16
Bacterial Infection	10	10
Sepsis	5	5
No Information	5	5
Death	3	3
Headache	2	2
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Drug Resistant Bacterial Infection	1	1
Fungus	1	1
Fungal Infection	1	1
Local Reaction	1	1
Blister	1	1
Crushing Injury	1	1
Injury	1	1
Fever	1	1
Exposure to Body Fluids	1	1
Pleural Effusion	1	1
Pain	1	1