TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
ANTICANCER INC
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	65	65
Low Test Results	34	34
Incorrect, Inadequate or Imprecise Result or Readings	15	15
Non Reproducible Results	15	15
Adverse Event Without Identified Device or Use Problem	14	14
Incorrect Or Inadequate Test Results	8	8
Device Handling Problem	4	4
No Apparent Adverse Event	4	4
Use of Device Problem	3	3
Appropriate Term/Code Not Available	3	3
Patient Device Interaction Problem	3	3
Imprecision	2	2
Incorrect Measurement	2	2
Low Readings	2	2
Improper or Incorrect Procedure or Method	2	2
Material Integrity Problem	1	1
Data Problem	1	1
False Positive Result	1	1
Erratic Results	1	1
Connection Problem	1	1
Sharp Edges	1	1
Fluid/Blood Leak	1	1
Mechanical Problem	1	1
Crack	1	1
Patient Data Problem	1	1
Unsealed Device Packaging	1	1
Device Contamination with Chemical or Other Material	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	41	41
No Consequences Or Impact To Patient	19	19
Insufficient Information	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	3	3
Injury	3	3
Abrasion	3	3
Bone Fracture(s)	2	2
Head Injury	2	2
Laceration(s)	2	2
Test Result	2	2
Muscle/Tendon Damage	1	1
Concussion	1	1
Bruise/Contusion	1	1
Eye Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Oct-14-2021
2	Ortho-Clinical Diagnostics	II	Nov-06-2018
3	Siemens Healthcare Diagnostics, Inc.	II	May-04-2018
4	Siemens Healthcare Diagnostics, Inc.	II	Jun-27-2012
5	Tosoh Bioscience Inc	II	Dec-22-2018
6	Tosoh Smd Inc	III	Dec-26-2019