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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorometer, for clinical use
Product CodeKHO
Regulation Number 862.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 65 65
2015 30 30
2016 35 35
2017 149 149
2018 2123 2123
2019 440 496
2020 257 257
2021 213 213
2022 224 224
2023 260 260
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 1147 1201
Device Displays Incorrect Message 879 879
Device Operates Differently Than Expected 633 633
Device Operational Issue 542 542
Incorrect, Inadequate or Imprecise Result or Readings 398 412
Device Issue 369 369
High Test Results 113 113
Incorrect Or Inadequate Test Results 84 84
Imprecision 74 74
Electrical /Electronic Property Problem 64 64
Failure to Align 63 63
Output Problem 59 59
Maintenance Does Not Comply To Manufacturers Recommendations 48 48
False Reading From Device Non-Compliance 48 48
High Readings 40 40
Obstruction of Flow 39 39
Low Test Results 32 32
Leak/Splash 29 29
Fluid/Blood Leak 24 24
Use of Device Problem 24 24
Low Readings 22 22
Computer Software Problem 22 24
Calibration Problem 20 20
Noise, Audible 20 20
Temperature Problem 19 19
Infusion or Flow Problem 15 15
Mechanical Jam 14 14
Display or Visual Feedback Problem 12 12
Bent 12 12
Improper or Incorrect Procedure or Method 12 12
Loose or Intermittent Connection 11 11
Device Sensing Problem 10 10
Complete Blockage 9 9
Patient Data Problem 8 8
Partial Blockage 8 8
Break 8 8
Material Twisted/Bent 8 8
Non Reproducible Results 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Pump 7 7
Failure to Calibrate 7 7
No Display/Image 7 7
Suction Problem 7 7
Device Maintenance Issue 7 7
Human Factors Issue 6 6
Computer Operating System Problem 6 6
Nonstandard Device 6 6
No Flow 6 6
Decreased Sensitivity 6 6
Communication or Transmission Problem 6 6
Suction Failure 6 6
Contamination 6 6
Device Ingredient or Reagent Problem 6 6
False Positive Result 5 5
Priming Problem 5 5
Connection Problem 5 5
Electrical Power Problem 5 5
Intermittent Continuity 5 5
Incorrect Measurement 5 5
Physical Property Issue 5 5
Image Display Error/Artifact 5 5
Air/Gas in Device 4 4
Material Deformation 4 4
Electrical Shorting 3 3
Pressure Problem 3 3
Detachment of Device or Device Component 3 3
Naturally Worn 3 3
Appropriate Term/Code Not Available 3 3
Display Difficult to Read 3 3
Power Problem 3 3
Defective Component 3 3
Data Problem 3 3
Fracture 2 2
Failure to Deliver 2 2
Degraded 2 2
Component Missing 2 2
Deformation Due to Compressive Stress 2 2
Intermittent Communication Failure 2 2
Inaccurate Delivery 2 2
Malposition of Device 2 2
Unable to Obtain Readings 2 2
Disconnection 2 2
Volume Accuracy Problem 2 2
Aspiration Issue 2 2
Fitting Problem 2 2
Loss of Power 2 2
False Device Output 2 2
Positioning Failure 2 2
Failure to Power Up 2 2
Inadequate or Insufficient Training 2 2
Application Network Problem 1 1
Device Handling Problem 1 1
Air Leak 1 1
Operating System Version or Upgrade Problem 1 1
Detachment Of Device Component 1 1
Sticking 1 1
Device Contamination With Biological Material 1 1
Failure to Clean Adequately 1 1
Optical Problem 1 1
Chemical Spillage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2938 2994
No Clinical Signs, Symptoms or Conditions 812 812
Misdiagnosis 46 46
No Information 45 45
No Consequences Or Impact To Patient 24 24
Insufficient Information 10 10
Test Result 3 3
Thrombus 2 2
Missing Value Reason 2 2
No Code Available 1 1
Electric Shock 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II May-06-2019
2 Ortho-Clinical Diagnostics II Jan-27-2012
3 PerkinElmer Health Sciences, Inc. III Oct-11-2018
4 PerkinElmer Life and Analytical Sciences, Wallac, OY II Jan-27-2017
5 PerkinElmer Life and Analytical Sciences, Wallac, OY II Feb-28-2012
6 Tecan US, Inc. II Jul-02-2015
7 Tecan US, Inc. III Jan-15-2015
8 Tosoh Bioscience Inc II Jun-23-2020
9 Tosoh Bioscience Inc II Feb-11-2020
10 Tosoh Bioscience Inc II Dec-14-2018
11 Tosoh Bioscience Inc II Dec-13-2018
12 Tosoh Bioscience Inc II Dec-13-2018
13 Tosoh Bioscience Inc II Dec-06-2018
14 Tosoh Bioscience Inc II Nov-28-2018
15 Tosoh Bioscience Inc II Nov-19-2018
16 Tosoh Bioscience Inc II Nov-16-2018
17 Tosoh Bioscience Inc II Nov-14-2018
18 Tosoh Bioscience Inc II Jan-31-2018
19 Tosoh Smd Inc II Jul-30-2013
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