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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colorimeter, photometer, spectrophotometer for clinical use
Product CodeJJQ
Regulation Number 862.2300
Device Class 1

MDR Year MDR Reports MDR Events
2017 9 9
2018 2 2
2019 1 1
2021 3 3
2022 22 22
2023 14 14
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 17 17
False Negative Result 11 11
Fire 6 6
Low Readings 3 3
Use of Device Problem 3 3
Calibration Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Electrical Shorting 2 2
Low Test Results 2 2
Noise, Audible 2 2
Excessive Heating 2 2
Device Operates Differently Than Expected 2 2
Electrical /Electronic Property Problem 2 2
Smoking 2 2
Mechanical Problem 1 1
Nonstandard Device 1 1
Melted 1 1
False Positive Result 1 1
Non Reproducible Results 1 1
Unintended Electrical Shock 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
No Known Impact Or Consequence To Patient 8 8
No Information 2 2
Dyspnea 2 2
Red Eye(s) 1 1
Swelling 1 1
No Patient Involvement 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Nov-18-2022
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