TPLC - Total Product Life Cycle

• Device: prescription use blood glucose meter for near-patient testing
• Definition: Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
• Product Code: PZI
• Regulation Number: 862.1345
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARKRAY, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	10

MDR Year	MDR Reports	MDR Events
2019	19	19
2020	8	8
2021	18	18
2022	7	7
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Patient Data Problem	15	15
Overheating of Device	4	4
Erratic Results	4	4
Smoking	3	3
Low Test Results	3	3
Complete Loss of Power	2	2
Melted	2	2
Sparking	2	2
Expiration Date Error	1	1
No Apparent Adverse Event	1	1
Use of Device Problem	1	1
Failure to Transmit Record	1	1
Non Reproducible Results	1	1
Thermal Decomposition of Device	1	1
Defective Device	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21	21
No Known Impact Or Consequence To Patient	15	15
No Information	5	5
No Consequences Or Impact To Patient	4	4
Insufficient Information	3	3
Needle Stick/Puncture	2	2
No Patient Involvement	1	1
Peripheral Edema	1	1
Hyperglycemia	1	1
Hypoglycemia	1	1
Unspecified Infection	1	1
Sepsis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1