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U.S. Department of Health and Human Services

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 CodeJQP
Regulation Number 862.2100
Device Class 1

MDR Year MDR Reports MDR Events
2020 52 52
2021 105 105
2022 166 166
2023 173 173
2024 102 102
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 184 184
Computer Software Problem 77 77
Application Program Problem 53 53
Product Quality Problem 41 41
Patient Data Problem 35 35
Insufficient Information 22 22
Installation-Related Problem 18 18
Smoking 14 14
Data Problem 14 14
False Positive Result 14 14
False Negative Result 11 11
Fail-Safe Problem 10 10
Low Test Results 10 10
Non Reproducible Results 8 8
Unintended Movement 7 7
Thermal Decomposition of Device 7 7
High Test Results 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Use of Device Problem 6 6
Communication or Transmission Problem 5 5
No Apparent Adverse Event 5 5
Leak/Splash 5 5
Mechanical Jam 5 5
Mechanical Problem 4 4
Application Program Version or Upgrade Problem 4 4
Output Problem 4 4
Device Fell 3 3
Unable to Obtain Readings 3 3
Missing Test Results 3 3
Human-Device Interface Problem 3 3
Device Handling Problem 3 3
Detachment of Device or Device Component 2 2
Device Contamination with Body Fluid 2 2
Failure to Transmit Record 2 2
Sparking 2 2
Overheating of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Circuit Failure 2 2
Problem with Software Installation 2 2
Sharp Edges 2 2
Flare or Flash 2 2
Protective Measures Problem 2 2
Program or Algorithm Execution Failure 2 2
Computer System Security Problem 2 2
Program or Algorithm Execution Problem 2 2
Shipping Damage or Problem 1 1
Missing Information 1 1
Electrical Power Problem 1 1
Fire 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 484 484
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
Abrasion 2 2
Bone Fracture(s) 2 2
Sepsis 2 2
Concussion 2 2
Viral Infection 1 1
Neck Pain 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Erosion 1 1
Bruise/Contusion 1 1
Congenital Defect/Deformity 1 1
Cardiac Enzyme Elevation 1 1
Head Injury 1 1
Unspecified Infection 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Muscle/Tendon Damage 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Unspecified Heart Problem 1 1
Neonatal Deformities 1 1
Skin Erosion 1 1
Electrolyte Imbalance 1 1
Heart Failure 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
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