TPLC - Total Product Life Cycle

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Device	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	194	194
Missing Information	173	173
Computer Software Problem	92	92
Application Program Problem	52	52
Patient Data Problem	47	47
Product Quality Problem	41	41
Insufficient Information	22	22
Installation-Related Problem	19	19
Data Problem	16	16
False Negative Result	13	13
Smoking	13	13
False Positive Result	13	13
Fail-Safe Problem	12	12
Low Test Results	11	12
Use of Device Problem	11	11
Non Reproducible Results	9	9
Thermal Decomposition of Device	9	9
No Apparent Adverse Event	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Unintended Movement	7	7
High Test Results	7	7
Output Problem	6	6
Mechanical Problem	6	6
Application Program Version or Upgrade Problem	5	5
Mechanical Jam	5	5
Improper or Incorrect Procedure or Method	4	4
Communication or Transmission Problem	4	4
Leak/Splash	4	4
Overheating of Device	4	4
Device Markings/Labelling Problem	3	3
Electrical /Electronic Property Problem	3	3
Device Fell	3	3
Device Handling Problem	3	3
Missing Test Results	3	3
Human-Device Interface Problem	3	3
Unable to Obtain Readings	3	3
Detachment of Device or Device Component	2	2
Circuit Failure	2	2
Sparking	2	2
Sharp Edges	2	2
Flare or Flash	2	2
Program or Algorithm Execution Problem	2	2
Problem with Software Installation	2	2
Computer System Security Problem	2	2
Loss of Data	2	2
Failure to Transmit Record	2	2
Program or Algorithm Execution Failure	2	2
Device Contamination with Body Fluid	2	2
No Device Output	1	1
Application Network Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	472	472
No Patient Involvement	196	196
No Known Impact Or Consequence To Patient	54	55
No Consequences Or Impact To Patient	52	52
Insufficient Information	46	46
Laceration(s)	8	8
No Code Available	3	3
Bone Fracture(s)	3	3
Headache	3	3
Sepsis	2	2
Abrasion	2	2
Concussion	2	2
Unspecified Infection	1	1
Arrhythmia	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
Missing Value Reason	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
Therapeutic Effects, Unexpected	1	1
Cancer	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories, Inc	II	Sep-26-2019
2	Beckman Coulter Inc.	II	Aug-23-2021
3	Beckman Coulter Inc.	II	Nov-18-2019
4	Beckman Coulter Inc.	II	Jul-17-2019
5	Beckman Coulter, Inc.	II	Aug-11-2021
6	Becton Dickinson & Co.	II	Dec-03-2024
7	Becton Dickinson & Co.	II	Oct-08-2024
8	Becton Dickinson & Co.	II	Jul-06-2023
9	Becton Dickinson & Co.	II	Apr-29-2022
10	Becton Dickinson & Co.	II	Mar-23-2019
11	Inpeco S.A.	II	May-28-2020
12	Inpeco S.A.	II	May-26-2020
13	Normand-Info S.A.S.U.	II	Jun-08-2021
14	Normand-Info S.A.S.U.	II	Jul-31-2020
15	Normand-Info S.A.S.U.	II	Mar-03-2020
16	Roche Diabetes Care, Inc.	II	Apr-26-2022
17	Roche Diagnostics Corporation	III	Jul-03-2019
18	Roche Diagnostics Corporation	II	May-17-2019
19	Roche Diagnostics Operations, Inc.	II	Jan-12-2023
20	Roche Diagnostics Operations, Inc.	II	Sep-10-2021
21	Roche Diagnostics Operations, Inc.	II	Jan-22-2021
22	Roche Diagnostics Operations, Inc.	II	Nov-17-2020
23	Roche Diagnostics Operations, Inc.	II	Feb-12-2020
24	Roche Diagnostics Operations, Inc.	II	Jan-30-2020
25	Siemens Healthcare Diagnostics, Inc.	II	Apr-18-2019
26	Soft Computer Consultants, Inc.	II	Jul-20-2021
27	Soft Computer Consultants, Inc.	II	Jul-19-2021
28	Technidata S.A.	II	May-10-2023