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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
2021 105 106
2022 166 170
2023 171 173
2024 102 104
2025 119 119
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 205 206
Computer Software Problem 103 103
Application Program Problem 60 63
Product Quality Problem 41 41
Patient Data Problem 38 39
Insufficient Information 27 27
Installation-Related Problem 21 21
Fail-Safe Problem 17 17
False Positive Result 16 17
Data Problem 15 15
Smoking 14 14
False Negative Result 12 13
Low Test Results 10 11
Non Reproducible Results 10 12
Thermal Decomposition of Device 8 8
Use of Device Problem 8 8
Electrical Shorting 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Output Problem 7 8
Mechanical Problem 7 7
Leak/Splash 7 7
Mechanical Jam 6 6
High Test Results 6 6
Unintended Movement 5 5
Application Program Version or Upgrade Problem 4 4
Failure to Transmit Record 4 4
Unable to Obtain Readings 4 4
Fire 4 4
Improper or Incorrect Procedure or Method 4 4
Device Fell 3 3
Program or Algorithm Execution Failure 3 3
Human-Device Interface Problem 3 3
Communication or Transmission Problem 3 3
Sharp Edges 3 3
Missing Test Results 3 3
Protective Measures Problem 2 2
Overheating of Device 2 2
Missing Information 2 2
No Apparent Adverse Event 2 2
Computer System Security Problem 2 2
Detachment of Device or Device Component 2 2
Application Program Problem: Parameter Calculation Error 2 2
Incorrect Measurement 2 2
Device Handling Problem 2 2
No Device Output 2 2
Circuit Failure 2 2
Device Contamination with Body Fluid 2 2
Flare or Flash 2 2
Program or Algorithm Execution Problem 2 2
Problem with Software Installation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 604 613
Insufficient Information 53 53
Laceration(s) 9 9
No Consequences Or Impact To Patient 7 7
Bone Fracture(s) 3 3
Headache 3 3
Sepsis 2 2
Abrasion 2 2
No Patient Involvement 2 2
Exposure to Body Fluids 2 2
Concussion 2 2
Unspecified Infection 1 1
Arrhythmia 1 1
Breast Mass 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
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 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 Medical Information Technology, Inc. II Sep-16-2025
10 Normand-Info S.A.S.U. II Jun-08-2021
11 Roche Diabetes Care, Inc. II Apr-26-2022
12 Roche Diagnostics Operations, Inc. II Jan-12-2023
13 Roche Diagnostics Operations, Inc. II Sep-10-2021
14 Roche Diagnostics Operations, Inc. II Jan-22-2021
15 Soft Computer Consultants, Inc. II Jul-20-2021
16 Soft Computer Consultants, Inc. II Jul-19-2021
17 Technidata S.A. II May-10-2023
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