TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	54	54
Low Test Results	24	24
Non Reproducible Results	14	14
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Adverse Event Without Identified Device or Use Problem	6	6
Device Handling Problem	4	4
Patient Device Interaction Problem	3	3
Use of Device Problem	3	3
Appropriate Term/Code Not Available	3	3
Incorrect Measurement	2	2
No Apparent Adverse Event	2	2
Low Readings	2	2
Material Integrity Problem	1	1
Sharp Edges	1	1
Mechanical Problem	1	1
Unsealed Device Packaging	1	1
Improper or Incorrect Procedure or Method	1	1
Crack	1	1
False Positive Result	1	1
Fluid/Blood Leak	1	1
Imprecision	1	1
Erratic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	71	71
No Known Impact Or Consequence To Patient	11	11
Insufficient Information	7	7
No Consequences Or Impact To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Injury	3	3
Abrasion	3	3
Bone Fracture(s)	2	2
Head Injury	2	2
Laceration(s)	2	2
Concussion	1	1
Bruise/Contusion	1	1
Eye Injury	1	1
Test Result	1	1
No Code Available	1	1
Muscle/Tendon Damage	1	1