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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

MDR Year MDR Reports MDR Events
2019 64 83
2020 21 99
2021 13 13
2022 15 15
2023 19 19
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 41 42
False Positive Result 18 113
Non Reproducible Results 13 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
High Test Results 13 13
Patient Data Problem 8 8
Incorrect Measurement 6 6
Electrical /Electronic Property Problem 6 6
Fire 4 4
Smoking 2 2
Insufficient Information 2 2
Computer Operating System Problem 2 2
No Device Output 2 2
Low Test Results 2 2
Output Problem 2 2
Communication or Transmission Problem 2 2
Leak/Splash 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Electrical Shorting 1 1
Low Readings 1 1
Computer Software Problem 1 1
Delayed Program or Algorithm Execution 1 1
Mechanical Jam 1 1
Device Displays Incorrect Message 1 1
Misfocusing 1 1
Optical Obstruction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 53 53
No Clinical Signs, Symptoms or Conditions 43 43
No Known Impact Or Consequence To Patient 15 112
Urinary Tract Infection 14 14
No Information 3 3
No Patient Involvement 3 3
Insufficient Information 3 3
Test Result 1 1
Chemical Exposure 1 1
Burn(s) 1 1
Eye Injury 1 1
Bacterial Infection 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-17-2023
7 Beckman Coulter, Inc. II Mar-20-2020
8 Roche Diagnostics Operations, Inc. II Nov-18-2021
9 Sysmex America, Inc. II Apr-15-2020
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