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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 59 59

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
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