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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device method, enzymatic, glucose (urinary, non-quantitative)
Product CodeJIL
Regulation Number 862.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ARKRAY INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 67 67
2020 23 23
2021 12 12
2022 14 14
2023 15 15
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 35 35
False Positive Result 21 21
Smoking 18 18
Low Test Results 17 17
High Test Results 13 13
Electrical /Electronic Property Problem 10 10
Non Reproducible Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Missing Information 5 5
Device Difficult to Setup or Prepare 2 2
Optical Problem 2 2
Patient Data Problem 2 2
Temperature Problem 1 1
Overheating of Device 1 1
Insufficient Information 1 1
No Device Output 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Computer Software Problem 1 1
Device Markings/Labelling Problem 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
High Readings 1 1
Low Readings 1 1
Missing Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 69 69
No Clinical Signs, Symptoms or Conditions 52 52
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 2 2
Urinary Frequency 1 1
Urinary Tract Infection 1 1
Pregnancy 1 1

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