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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
Regulation Description Glucose test system.
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 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 18 18
2022 7 7
2023 2 2
2024 5 5
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Patient Data Problem 12 12
Output Problem 8 8
Erratic Results 4 4
Overheating of Device 4 4
Low Test Results 4 4
High Test Results 3 3
Failure to Transmit Record 2 2
Smoking 2 2
Computer Software Problem 2 2
Melted 2 2
Complete Loss of Power 2 2
Sparking 1 1
Non Reproducible Results 1 1
Defective Device 1 1
Use of Device Problem 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Human-Device Interface Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 3 3
No Information 2 2
Needle Stick/Puncture 2 2
Hypoglycemia 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cyanosis 1 1
Apnea 1 1
Sepsis 1 1
Peripheral Edema 1 1
No Known Impact Or Consequence To Patient 1 1
Hyperglycemia 1 1
Hypothermia 1 1
Bradycardia 1 1
Shaking/Tremors 1 1
Convulsion/Seizure 1 1
Respiratory Distress Syndrome of Newborns 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nova Biomedical Corporation I Dec-20-2024
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