TPLC - Total Product Life Cycle

• Device: automated urinalysis system
• Product Code: KQO
• Regulation Number: 862.2900
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	21	99
2021	13	13
2022	15	15
2023	19	19
2024	20	20

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	39	40
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Incorrect Measurement	6	6
False Positive Result	6	82
Non Reproducible Results	5	6
Electrical /Electronic Property Problem	3	3
Fire	2	2
Communication or Transmission Problem	2	2
Output Problem	2	2
Smoking	2	2
Computer Operating System Problem	2	2
No Device Output	2	2
Low Test Results	2	2
Leak/Splash	1	1
Insufficient Information	1	1
High Readings	1	1
Unable to Obtain Readings	1	1
Low Readings	1	1
Electrical Shorting	1	1
Computer Software Problem	1	1
Delayed Program or Algorithm Execution	1	1
Optical Obstruction	1	1
Device Displays Incorrect Message	1	1
Mechanical Jam	1	1
Misfocusing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
Urinary Tract Infection	12	12
No Known Impact Or Consequence To Patient	6	84
No Consequences Or Impact To Patient	5	5
Insufficient Information	3	3
Test Result	1	1
No Information	1	1
No Patient Involvement	1	1
Eye Injury	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	May-09-2020
2	Beckman Coulter Inc.	II	Jan-29-2020
3	Beckman Coulter Inc.	II	Jan-23-2020
4	Beckman Coulter, Inc.	II	May-17-2023
5	Beckman Coulter, Inc.	II	Mar-20-2020
6	Roche Diagnostics Operations, Inc.	II	Nov-18-2021
7	Sysmex America, Inc.	II	Apr-15-2020