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	185	185
Computer Software Problem	81	81
Application Program Problem	53	53
Product Quality Problem	41	41
Patient Data Problem	35	35
Insufficient Information	22	22
Installation-Related Problem	18	18
Data Problem	15	15
False Positive Result	14	14
Smoking	14	14
False Negative Result	11	11
Fail-Safe Problem	11	11
Low Test Results	10	10
Non Reproducible Results	8	8
Adverse Event Without Identified Device or Use Problem	8	8
High Test Results	7	7
Unintended Movement	7	7
Thermal Decomposition of Device	7	7
Leak/Splash	6	6
Use of Device Problem	6	6
Mechanical Jam	5	5
No Apparent Adverse Event	5	5
Communication or Transmission Problem	5	5
Mechanical Problem	4	4
Output Problem	4	4
Application Program Version or Upgrade Problem	4	4
Human-Device Interface Problem	3	3
Device Handling Problem	3	3
Missing Test Results	3	3
Unable to Obtain Readings	3	3
Device Fell	3	3
Problem with Software Installation	2	2
Circuit Failure	2	2
Improper or Incorrect Procedure or Method	2	2
Program or Algorithm Execution Problem	2	2
Failure to Transmit Record	2	2
Flare or Flash	2	2
Program or Algorithm Execution Failure	2	2
Computer System Security Problem	2	2
Overheating of Device	2	2
Sharp Edges	2	2
Sparking	2	2
Protective Measures Problem	2	2
Detachment of Device or Device Component	2	2
Electrical Shorting	2	2
Device Contamination with Body Fluid	2	2
Temperature Problem	1	1
Inadequate User Interface	1	1
No Device Output	1	1
Unintended Collision	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	491	491
Insufficient Information	46	46
No Consequences Or Impact To Patient	29	29
No Known Impact Or Consequence To Patient	16	16
No Patient Involvement	11	11
Laceration(s)	7	7
Headache	3	3
Sepsis	2	2
Bone Fracture(s)	2	2
Abrasion	2	2
Concussion	2	2
Unspecified Infection	1	1
Arrhythmia	1	1
No Code Available	1	1
Neonatal Deformities	1	1
No Information	1	1
Head Injury	1	1
Heart Failure	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Electrolyte Imbalance	1	1
Skin Erosion	1	1
Neck Pain	1	1
Exposure to Body Fluids	1	1
Viral Infection	1	1
Congenital Defect/Deformity	1	1
Muscle/Tendon Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Unspecified Heart Problem	1	1
Erosion	1	1
Cardiac Enzyme Elevation	1	1
Bruise/Contusion	1	1

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