TPLC - Total Product Life Cycle

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Device	system, detection, bacterial, for platelet transfusion products
Product Code	MZC
Regulation Number	866.2560
Device Class	1

Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON & COMPANY
	SUBSTANTIALLY EQUIVALENT	2
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	3
IMMUNETICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
PALL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VERAX BIOMEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	24	24
False Positive Result	20	20
Missing Information	2	2
Incorrect Or Inadequate Test Results	2	2
Insufficient Information	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Fluid/Blood Leak	1	1
Contamination of Device Ingredient or Reagent	1	1
Contamination	1	1
Improper or Incorrect Procedure or Method	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18	18
No Known Impact Or Consequence To Patient	14	14
No Patient Involvement	6	6
Fever	5	5
Nausea	4	4
Bacterial Infection	3	3
Tachycardia	3	3
Vomiting	3	3
Chills	3	3
Reaction	3	3
No Consequences Or Impact To Patient	2	2
Death	2	2
Rash	2	2
Sepsis	2	2
Septic Shock	2	2
Dyspnea	1	1
Pain	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Laceration(s)	1	1
Complaint, Ill-Defined	1	1
Chest Tightness/Pressure	1	1
Respiratory Failure	1	1
Lethargy	1	1