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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated urinalysis system
Product CodeKQO
Regulation Number 862.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARJ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
DFI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
YD DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 106 106
2015 238 238
2016 373 373
2017 20 20
2018 25 25
2019 64 83
2020 21 99
2021 13 13
2022 15 15
2023 19 19
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 359 359
False Negative Result 258 259
Incorrect, Inadequate or Imprecise Result or Readings 145 145
Leak/Splash 51 51
False Positive Result 30 125
Fluid/Blood Leak 29 29
Device Inoperable 26 26
High Test Results 25 25
Incorrect Or Inadequate Test Results 25 25
Low Test Results 23 23
Output Problem 21 21
Patient Data Problem 17 17
Device Operational Issue 16 16
Thermal Decomposition of Device 15 15
Charred 14 14
Non Reproducible Results 13 14
Smoking 13 13
Electrical /Electronic Property Problem 12 12
Device Emits Odor 12 12
Loose or Intermittent Connection 8 8
Issue With Displayed Error Message 7 7
Improper or Incorrect Procedure or Method 6 6
Optical Distortion 6 6
Incorrect Measurement 6 6
Computer Software Problem 6 6
Device Displays Incorrect Message 5 5
Melted 4 4
Improper Device Output 4 4
Communication or Transmission Problem 4 4
Fire 4 4
Data Problem 3 3
Product Quality Problem 3 3
Pumping Problem 3 3
Mechanical Jam 3 3
Protective Measures Problem 3 3
Computer Operating System Problem 2 2
Device-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Electrical Shorting 2 2
Device Markings/Labelling Problem 2 2
Misfocusing 2 2
Insufficient Information 2 2
No Device Output 2 2
Crack 2 2
False Reading From Device Non-Compliance 2 2
Failure to Prime 2 2
No Flow 2 2
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Increase in Pressure 1 1
Optical Obstruction 1 1
Invalid Sensing 1 1
High Readings 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Physical Property Issue 1 1
Inadequate Lighting 1 1
No Display/Image 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Missing Test Results 1 1
Material Twisted/Bent 1 1
Application Program Version or Upgrade Problem 1 1
Sparking 1 1
Loss of Data 1 1
Low Readings 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Display Difficult to Read 1 1
Device Stops Intermittently 1 1
Power Conditioning Problem 1 1
Device Expiration Issue 1 1
Improper Flow or Infusion 1 1
Mechanical Problem 1 1
Defective Device 1 1
Overheating of Device 1 1
Packaging Problem 1 1
Calibration Problem 1 1
Unable to Obtain Readings 1 1
Failure of Device to Self-Test 1 1
Accessory Incompatible 1 1
Incorrect Device Or Component Shipped 1 1
Poor Quality Image 1 1
False Device Output 1 1
Loss of Power 1 1
Delayed Program or Algorithm Execution 1 1
Hole In Material 1 1
Use of Incorrect Control/Treatment Settings 1 1
Altitude variations 1 1
Application Program Problem 1 1
Component or Accessory Incompatibility 1 1
Device Handling Problem 1 1
Failure to Power Up 1 1
Installation-Related Problem 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 608 705
No Consequences Or Impact To Patient 165 165
No Clinical Signs, Symptoms or Conditions 41 41
Not Applicable 32 32
Urinary Tract Infection 18 18
No Patient Involvement 18 18
Test Result 9 9
No Information 3 3
Insufficient Information 3 3
Eye Injury 2 2
Irritation 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Death 1 1
Complaint, Ill-Defined 1 1
Chemical Exposure 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arkray Factory USA, Inc. II Jun-20-2019
2 Beckman Coulter Inc. II May-09-2020
3 Beckman Coulter Inc. II Jan-29-2020
4 Beckman Coulter Inc. II Jan-23-2020
5 Beckman Coulter Inc. II Jul-03-2019
6 Beckman Coulter Inc. II May-04-2018
7 Beckman Coulter Inc. II Apr-27-2018
8 Beckman Coulter Inc. II Apr-12-2018
9 Beckman Coulter Inc. II Apr-11-2018
10 Beckman Coulter Inc. II Mar-01-2017
11 Beckman Coulter Inc. II Mar-08-2016
12 Beckman Coulter, Inc. II May-17-2023
13 Beckman Coulter, Inc. II Mar-20-2020
14 HemoCue AB II Oct-25-2013
15 Iris Diagnostics II Aug-21-2015
16 Roche Diagnostics Operations, Inc. II Nov-18-2021
17 Siemens Healthcare Diagnostics Inc III May-04-2014
18 Sysmex America, Inc. II Apr-15-2020
19 Teco Diagnostics II Jan-11-2012
20 Teco Diagnostics II Dec-09-2010
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