TPLC - Total Product Life Cycle

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Device	calculator/data processing module, for clinical use
Regulation Description	Calculator/data processing module for clinical use.
Product Code	JQP
Regulation Number	862.2100
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	211	212
Computer Software Problem	101	101
Application Program Problem	64	67
Product Quality Problem	41	41
Patient Data Problem	40	41
Insufficient Information	28	28
Installation-Related Problem	20	20
False Positive Result	16	17
Data Problem	16	16
Smoking	15	15
Fail-Safe Problem	15	15
False Negative Result	13	14
Low Test Results	11	12
Non Reproducible Results	10	12
Thermal Decomposition of Device	8	8
Use of Device Problem	8	8
Unintended Movement	8	8
Output Problem	8	9
Leak/Splash	8	8
High Test Results	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Mechanical Jam	6	6
Communication or Transmission Problem	5	5
Mechanical Problem	5	5
No Apparent Adverse Event	5	5
Electrical Shorting	5	5
Device Fell	5	5
Unable to Obtain Readings	4	4
Application Program Version or Upgrade Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Fire	4	4
Device Handling Problem	3	3
Program or Algorithm Execution Failure	3	3
Sharp Edges	3	3
Human-Device Interface Problem	3	3
Missing Test Results	3	3
Program or Algorithm Execution Problem	2	2
Failure to Transmit Record	2	2
Overheating of Device	2	2
Flare or Flash	2	2
Protective Measures Problem	2	2
Incorrect Measurement	2	2
Detachment of Device or Device Component	2	2
Sparking	2	2
No Device Output	2	2
Circuit Failure	2	2
Missing Information	2	2
Problem with Software Installation	2	2
Device Contamination with Body Fluid	2	2
Computer System Security Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	587	596
Insufficient Information	49	49
No Consequences Or Impact To Patient	29	29
No Known Impact Or Consequence To Patient	16	16
No Patient Involvement	11	11
Laceration(s)	9	9
Headache	3	3
Bone Fracture(s)	3	3
Sepsis	2	2
Abrasion	2	2
Exposure to Body Fluids	2	2
Concussion	2	2
Breast Mass	1	1
Heart Failure	1	1
Neck Pain	1	1
Electrolyte Imbalance	1	1
Unspecified Heart Problem	1	1
No Code Available	1	1
Unspecified Infection	1	1
Neonatal Deformities	1	1
No Information	1	1
Cardiac Enzyme Elevation	1	1
Partial thickness (Second Degree) Burn	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Erosion	1	1
Arrhythmia	1	1
Head Injury	1	1
Muscle/Tendon Damage	1	1
Bruise/Contusion	1	1
Unspecified Respiratory Problem	1	1
Viral Infection	1	1
Congenital Defect/Deformity	1	1
Skin Erosion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Jun-25-2025
2	Beckman Coulter Inc.	II	Aug-23-2021
3	Beckman Coulter, Inc.	II	Aug-11-2021
4	Becton Dickinson & Co.	II	Oct-23-2025
5	Becton Dickinson & Co.	II	Dec-03-2024
6	Becton Dickinson & Co.	II	Oct-08-2024
7	Becton Dickinson & Co.	II	Jul-06-2023
8	Becton Dickinson & Co.	II	Apr-29-2022
9	Inpeco S.A.	II	May-28-2020
10	Inpeco S.A.	II	May-26-2020
11	Medical Information Technology, Inc.	II	Sep-16-2025
12	Normand-Info S.A.S.U.	II	Jun-08-2021
13	Normand-Info S.A.S.U.	II	Jul-31-2020
14	Normand-Info S.A.S.U.	II	Mar-03-2020
15	Roche Diabetes Care, Inc.	II	Apr-26-2022
16	Roche Diagnostics Operations, Inc.	II	Jan-12-2023
17	Roche Diagnostics Operations, Inc.	II	Sep-10-2021
18	Roche Diagnostics Operations, Inc.	II	Jan-22-2021
19	Roche Diagnostics Operations, Inc.	II	Nov-17-2020
20	Roche Diagnostics Operations, Inc.	II	Feb-12-2020
21	Roche Diagnostics Operations, Inc.	II	Jan-30-2020
22	Soft Computer Consultants, Inc.	II	Jul-20-2021
23	Soft Computer Consultants, Inc.	II	Jul-19-2021
24	Technidata S.A.	II	May-10-2023