TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BD DIAGNOSTIC SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	2303	2303
False Positive Result	2171	2171
False Negative Result	411	411
Contamination	335	335
Device Markings/Labelling Problem	125	125
Leak/Splash	112	112
Cross Reactivity	103	103
Contamination of Device Ingredient or Reagent	47	47
Microbial Contamination of Device	31	31
Missing Information	19	19
Unintended Movement	19	19
Fluid/Blood Leak	17	17
Break	14	14
Device Contamination with Chemical or Other Material	13	13
Inaccurate Information	8	8
Fire	6	6
Device Ingredient or Reagent Problem	6	6
Contamination /Decontamination Problem	4	4
Data Problem	4	4
Mechanical Problem	4	4
Failure to Obtain Sample	3	3
Patient Data Problem	3	3
Crack	3	3
Incorrect Measurement	3	3
Patient-Device Incompatibility	2	2
Unintended Electrical Shock	2	2
Device Damaged Prior to Use	2	2
Missing Test Results	2	2
Labelling, Instructions for Use or Training Problem	2	2
Product Quality Problem	2	2
Communication or Transmission Problem	2	2
Device-Device Incompatibility	2	2
Defective Component	1	1
Material Integrity Problem	1	1
Alarm Not Visible	1	1
Physical Resistance/Sticking	1	1
Backflow	1	1
Failure to Power Up	1	1
Structural Problem	1	1
Audible Prompt/Feedback Problem	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Body Fluid	1	1
Excessive Heating	1	1
Application Network Problem	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5620	5621
No Consequences Or Impact To Patient	116	116
Insufficient Information	38	38
Bacterial Infection	10	10
Sepsis	5	5
No Information	5	5
No Patient Involvement	5	5
Misdiagnosis	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Air Embolism	1	1
Drug Resistant Bacterial Infection	1	1
Fungal Infection	1	1
Crushing Injury	1	1
Local Reaction	1	1
Blister	1	1
Fever	1	1
Pleural Effusion	1	1