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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 10
  1.  K132121  STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
  2.  K150281  StatStrip Glucose Hospital Meter
  3.  K150461  StatStrip Xpress Glucose Hospital Meter System
  4.  K152986  StatStrip Xpress 2 Glucose Hospital Meter System
  5.  K161856  StatStrip Xpress Glucose Hospital Meter System
  6.  K163490  StatStrip Xpress 2 Glucose Hospital Meter System
  7.  K181043  StatStrip Glucose Hospital Meter System
  8.  K182549  StatStrip Xpress 2 Glucose Hospital Meter System
  9.  K182552  StatStrip Xpress Glucose Hospital Meter System
  10.  K232075  StatStrip Glucose Hospital Meter System
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

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
Erratic Results 4 4
Overheating of Device 4 4
Smoking 3 3
Low Test Results 3 3
Melted 2 2
Complete Loss of Power 2 2
Sparking 2 2
Protective Measures Problem 1 1
No Apparent Adverse Event 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
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

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