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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 CodePZI
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

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

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
Erratic Results 4 4
Overheating of Device 4 4
Smoking 3 3
Low Test Results 2 2
Melted 2 2
Complete Loss of Power 2 2
Sparking 2 2
Protective Measures Problem 1 1
Non Reproducible Results 1 1
Thermal Decomposition of Device 1 1
Failure to Transmit Record 1 1
Expiration Date Error 1 1
Defective Device 1 1
Use of Device 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
Hypoglycemia 1 1
Unspecified Infection 1 1
Sepsis 1 1

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