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	197	197
Computer Software Problem	92	92
Application Program Problem	56	56
Product Quality Problem	41	41
Patient Data Problem	35	35
Insufficient Information	23	23
Installation-Related Problem	20	20
False Positive Result	16	16
Data Problem	16	16
Smoking	15	15
False Negative Result	13	13
Fail-Safe Problem	13	13
Low Test Results	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Non Reproducible Results	8	8
Unintended Movement	8	8
Leak/Splash	7	7
High Test Results	7	7
Thermal Decomposition of Device	7	7
Mechanical Jam	6	6
Use of Device Problem	6	6
No Apparent Adverse Event	5	5
Mechanical Problem	5	5
Communication or Transmission Problem	5	5
Device Fell	5	5
Unable to Obtain Readings	4	4
Application Program Version or Upgrade Problem	4	4
Output Problem	4	4
Fire	3	3
Electrical Shorting	3	3
Improper or Incorrect Procedure or Method	3	3
Device Handling Problem	3	3
Human-Device Interface Problem	3	3
Missing Test Results	3	3
Sharp Edges	3	3
Failure to Transmit Record	2	2
Circuit Failure	2	2
Detachment of Device or Device Component	2	2
Program or Algorithm Execution Failure	2	2
Device Contamination with Body Fluid	2	2
Problem with Software Installation	2	2
Sparking	2	2
Program or Algorithm Execution Problem	2	2
Computer System Security Problem	2	2
Flare or Flash	2	2
Overheating of Device	2	2
Protective Measures Problem	2	2
Device Ingredient or Reagent Problem	1	1
Missing Information	1	1
Data Back-Up Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	537	537
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)	9	9
Bone Fracture(s)	3	3
Headache	3	3
Sepsis	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
Heart Failure	1	1
Head Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Electrolyte Imbalance	1	1
Neck Pain	1	1
Skin Erosion	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
Unspecified Respiratory 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	Jun-25-2025
2	Beckman Coulter Inc.	II	Aug-23-2021
3	Beckman Coulter, Inc.	II	Aug-11-2021
4	Becton Dickinson & Co.	II	Dec-03-2024
5	Becton Dickinson & Co.	II	Oct-08-2024
6	Becton Dickinson & Co.	II	Jul-06-2023
7	Becton Dickinson & Co.	II	Apr-29-2022
8	Inpeco S.A.	II	May-28-2020
9	Inpeco S.A.	II	May-26-2020
10	Normand-Info S.A.S.U.	II	Jun-08-2021
11	Normand-Info S.A.S.U.	II	Jul-31-2020
12	Normand-Info S.A.S.U.	II	Mar-03-2020
13	Roche Diabetes Care, Inc.	II	Apr-26-2022
14	Roche Diagnostics Operations, Inc.	II	Jan-12-2023
15	Roche Diagnostics Operations, Inc.	II	Sep-10-2021
16	Roche Diagnostics Operations, Inc.	II	Jan-22-2021
17	Roche Diagnostics Operations, Inc.	II	Nov-17-2020
18	Roche Diagnostics Operations, Inc.	II	Feb-12-2020
19	Roche Diagnostics Operations, Inc.	II	Jan-30-2020
20	Soft Computer Consultants, Inc.	II	Jul-20-2021
21	Soft Computer Consultants, Inc.	II	Jul-19-2021
22	Technidata S.A.	II	May-10-2023