TPLC - Total Product Life Cycle

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Device	radioimmunoassay, thyroid-stimulating hormone
Product Code	JLW
Regulation Number	862.1690
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	413	428
High Test Results	318	354
Non Reproducible Results	75	86
Incorrect, Inadequate or Imprecise Result or Readings	50	50
No Apparent Adverse Event	14	14
Adverse Event Without Identified Device or Use Problem	13	13
High Readings	10	10
Incorrect Measurement	6	6
Insufficient Information	6	6
Low Readings	3	3
Chemical Problem	3	3
Appropriate Term/Code Not Available	2	2
Output Problem	2	2
Material Integrity Problem	2	2
Device Damaged Prior to Use	1	1
Device Ingredient or Reagent Problem	1	1
Improper Chemical Reaction	1	1
Mechanical Problem	1	1
Unable to Obtain Readings	1	1
Cross Reactivity	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	487	487
No Consequences Or Impact To Patient	184	184
No Known Impact Or Consequence To Patient	164	225
Insufficient Information	6	6
No Patient Involvement	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Test Result	3	4
No Code Available	3	3
Hormonal Imbalance	1	1
Full thickness (Third Degree) Burn	1	1
Underdose	1	1
Hypothermia	1	1
Polymyositis	1	1
Thyroid Problems	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Roche Diagnostics Operations, Inc.	II	Oct-04-2019
2	Siemens Healthcare Diagnostics, Inc.	II	Jun-09-2022
3	Siemens Healthcare Diagnostics, Inc.	II	Jul-07-2021
4	Siemens Healthcare Diagnostics, Inc.	II	Nov-19-2020
5	Siemens Healthcare Diagnostics, Inc.	II	May-09-2019