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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
Regulation Description Fluorometer for clinical use.
Product CodeKHO
Regulation Number 862.2560
Device Class 1

MDR Year MDR Reports MDR Events
2016 35 35
2017 146 146
2018 2109 2109
2019 440 496
2020 257 257
2021 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 878 932
Device Displays Incorrect Message 877 877
Device Operates Differently Than Expected 630 630
Device Operational Issue 542 542
Device Issue 368 368
Incorrect, Inadequate or Imprecise Resultor Readings 302 316
Imprecision 74 74
Incorrect Or Inadequate Test Results 71 71
Output Problem 58 58
Maintenance Does Not Comply To Manufacturers Recommendations 48 48
False Reading From Device Non-Compliance 47 47
High Test Results 43 43
Electrical /Electronic Property Problem 33 33
Failure to Align 31 31
High Readings 29 29
Leak/Splash 24 24
Use of Device Problem 23 23
Low Test Results 20 20
Obstruction of Flow 20 20
Low Readings 19 19
Fluid Leak 18 18
Computer Software Problem 18 20
Calibration Problem 17 17
Noise, Audible 14 14
Bent 12 12
Temperature Problem 11 11
Mechanical Jam 10 10
Device Sensing Problem 9 9
Complete Blockage 9 9
Partial Blockage 8 8
Infusion or Flow Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Device Maintenance Issue 7 7
Break 6 6
Contamination 6 6
No Display/Image 6 6
Display or Visual Feedback Problem 6 6
Computer Operating System Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Physical Property Issue 5 5
Communication or Transmission Problem 5 5
Human Factors Issue 5 5
Loose or Intermittent Connection 5 5
Incorrect Measurement 5 5
Suction Problem 5 5
Failure to Calibrate 5 5
Nonstandard Device 4 4
Device Ingredient or Reagent Problem 4 4
Suction Failure 4 4
Material Deformation 3 3
Material Twisted/Bent 3 3
Connection Problem 3 3
Pressure Problem 3 3
Naturally Worn 3 3
Appropriate Term/Code Not Available 3 3
Patient Data Problem 3 3
Non Reproducible Results 3 3
Power Problem 2 2
Detachment of Device or Device Component 2 2
Electrical Power Problem 2 2
Air/Gas in Device 2 2
Fracture 2 2
False Device Output 2 2
Positioning Failure 2 2
Intermittent Continuity 2 2
Decreased Sensitivity 2 2
Malposition of Device 2 2
Aspiration Issue 2 2
Fitting Problem 2 2
Inaccurate Delivery 2 2
Failure to Pump 2 2
Unable to Obtain Readings 2 2
Failure to Recalibrate 1 1
Short Fill 1 1
Device Slipped 1 1
Sticking 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Defective Alarm 1 1
Volume Accuracy Problem 1 1
Defective Component 1 1
Component Missing 1 1
Blocked Connection 1 1
Split 1 1
Low Sensing Threshold 1 1
Chemical Spillage 1 1
Contamination /Decontamination Problem 1 1
Failure to Advance 1 1
Crack 1 1
Circuit Failure 1 1
Disconnection 1 1
Detachment Of Device Component 1 1
Device Expiration Issue 1 1
False Positive Result 1 1
Fire 1 1
Image Display Error/Artifact 1 1
Image Resolution Poor 1 1
Difficult to Flush 1 1
Overheating of Device 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2860 2916
No Clinical Signs, Symptoms or Conditions 237 237
Misdiagnosis 46 46
No Information 44 44
Insufficient Information 10 10
No Consequences Or Impact To Patient 6 6
Test Result 2 2
Thrombus 2 2
Missing Value Reason 2 2
No Code Available 1 1
Patient Problem/Medical Problem 1 1

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