TPLC - Total Product Life Cycle

• Device: test, natriuretic peptide
• Regulation Description: B-type natriuretic peptide test system.
• Product Code: NBC
• Regulation Number: 862.1117
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AXIS-SHIELD DIAGNOSTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	2
FUJIREBIO DIAGNOSTICS,INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOSOH BIOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	6	6
2022	4	4
2023	26	27
2024	14	15
2025	17	17
2026	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	54	55
Non Reproducible Results	19	20
High Test Results	17	18
Low Readings	3	4
Insufficient Information	2	3
Incorrect, Inadequate or Imprecise Result or Readings	2	3
High Readings	2	2
False Negative Result	1	1
Output Problem	1	1
Incorrect Measurement	1	1
Failure to Calibrate	1	1
False Positive Result	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	65	67
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Insufficient Information	2	2
No Known Impact Or Consequence To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medline Industries Inc	II	Oct-26-2020