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TPLC
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Device
automated urinalysis system
Product Code
KQO
Regulation Number
862.2900
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
Incorrect Or Inadequate Test Results
25
25
High 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
Smoking
13
13
Non Reproducible Results
13
14
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
Incorrect Measurement
6
6
Computer Software Problem
6
6
Optical Distortion
6
6
Device Displays Incorrect Message
5
5
Improper Device Output
4
4
Communication or Transmission Problem
4
4
Melted
4
4
Fire
4
4
Product Quality Problem
3
3
Mechanical Jam
3
3
Protective Measures Problem
3
3
Pumping Problem
3
3
Data Problem
3
3
Insufficient Information
2
2
No Flow
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Failure to Prime
2
2
No Device Output
2
2
Misfocusing
2
2
False Reading From Device Non-Compliance
2
2
Crack
2
2
Computer Operating System Problem
2
2
Device-Device Incompatibility
2
2
Electrical Shorting
2
2
Device Markings/Labelling Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Use of Device Problem
2
2
Device Stops Intermittently
1
1
Invalid Sensing
1
1
Obstruction of Flow
1
1
Failure to Calibrate
1
1
Sparking
1
1
Application Program Problem
1
1
Application Program Version or Upgrade Problem
1
1
Calibration Problem
1
1
High Readings
1
1
Low Readings
1
1
Defective Device
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Material Twisted/Bent
1
1
Improper Flow or Infusion
1
1
Inadequate Lighting
1
1
Incorrect Device Or Component Shipped
1
1
Installation-Related Problem
1
1
Failure of Device to Self-Test
1
1
Loss of Data
1
1
Component or Accessory Incompatibility
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Display Difficult to Read
1
1
No Display/Image
1
1
Complete Blockage
1
1
Accessory Incompatible
1
1
Altitude variations
1
1
False Device Output
1
1
Use of Incorrect Control/Treatment Settings
1
1
Device Expiration Issue
1
1
Poor Quality Image
1
1
Hole In Material
1
1
Mechanical Problem
1
1
Overheating of Device
1
1
Power Conditioning Problem
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Increase in Pressure
1
1
Unable to Obtain Readings
1
1
Optical Obstruction
1
1
Packaging Problem
1
1
Physical Property Issue
1
1
Delayed Program or Algorithm Execution
1
1
Device Handling Problem
1
1
Missing Test Results
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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