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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
Product CodeJQP
Regulation Number 862.2100
Device Class 1

MDR Year MDR Reports MDR Events
2019 253 254
2020 52 52
2021 105 105
2022 166 166
2023 173 173
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 177 177
Missing Information 173 173
Computer Software Problem 84 84
Application Program Problem 48 48
Patient Data Problem 46 46
Product Quality Problem 41 41
Insufficient Information 22 22
Data Problem 16 16
Installation-Related Problem 11 11
Smoking 11 11
Use of Device Problem 11 11
Low Test Results 11 12
False Negative Result 11 11
False Positive Result 10 10
Fail-Safe Problem 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Thermal Decomposition of Device 7 7
High Test Results 7 7
No Apparent Adverse Event 7 7
Non Reproducible Results 7 7
Output Problem 5 5
Unintended Movement 5 5
Mechanical Jam 4 4
Communication or Transmission Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Overheating of Device 4 4
Mechanical Problem 4 4
Leak/Splash 3 3
Electrical /Electronic Property Problem 3 3
Unable to Obtain Readings 3 3
Application Program Version or Upgrade Problem 3 3
Human-Device Interface Problem 3 3
Device Markings/Labelling Problem 3 3
Device Handling Problem 3 3
Missing Test Results 3 3
Device Fell 3 3
Sharp Edges 2 2
Loss of Data 2 2
Detachment of Device or Device Component 2 2
Flare or Flash 2 2
Computer System Security Problem 2 2
Sparking 2 2
Problem with Software Installation 2 2
Device Contamination with Body Fluid 2 2
Circuit Failure 2 2
Failure to Back-Up 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Degraded 1 1
Display or Visual Feedback Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
Incorrect Measurement 1 1
Material Fragmentation 1 1
Melted 1 1
Unintended Collision 1 1
Unintended System Motion 1 1
No Device Output 1 1
Device Damaged Prior to Use 1 1
Low Readings 1 1
Failure to Align 1 1
Arcing 1 1
Defective Device 1 1
Application Program Problem: Parameter Calculation Error 1 1
Unstable 1 1
Failure to Read Input Signal 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Unauthorized Access to Computer System 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Misassembly by Users 1 1
Power Problem 1 1
Application Program Problem: Medication Error 1 1
Application Network Problem 1 1
Data Back-Up Problem 1 1
Application Security Problem 1 1
Contamination /Decontamination Problem 1 1
Compatibility Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device-Device Incompatibility 1 1
Electrical Power Problem 1 1
Unintended Electrical Shock 1 1
Excessive Heating 1 1
Program or Algorithm Execution Problem 1 1
Delayed Program or Algorithm Execution 1 1
Intermittent Program or Algorithm Execution 1 1
Program or Algorithm Execution Failure 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 417 417
No Patient Involvement 196 196
No Known Impact Or Consequence To Patient 54 55
No Consequences Or Impact To Patient 52 52
Insufficient Information 37 37
Laceration(s) 8 8
Bone Fracture(s) 3 3
No Code Available 3 3
Abrasion 2 2
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
Headache 1 1
Unspecified Infection 1 1
Neonatal Deformities 1 1
Sepsis 1 1
Skin Erosion 1 1
Therapeutic Effects, Unexpected 1 1
Concussion 1 1
Electrolyte Imbalance 1 1
Heart Failure 1 1
Viral Infection 1 1
Neck Pain 1 1
Missing Value Reason 1 1
Cancer 1 1
Unspecified Heart Problem 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

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 Jul-06-2023
7 Becton Dickinson & Co. II Apr-29-2022
8 Becton Dickinson & Co. II Mar-23-2019
9 Inpeco S.A. II May-28-2020
10 Inpeco S.A. II May-26-2020
11 Normand-Info S.A.S.U. II Jun-08-2021
12 Normand-Info S.A.S.U. II Jul-31-2020
13 Normand-Info S.A.S.U. II Mar-03-2020
14 Roche Diabetes Care, Inc. II Apr-26-2022
15 Roche Diagnostics Corporation III Jul-03-2019
16 Roche Diagnostics Corporation II May-17-2019
17 Roche Diagnostics Operations, Inc. II Jan-12-2023
18 Roche Diagnostics Operations, Inc. II Sep-10-2021
19 Roche Diagnostics Operations, Inc. II Jan-22-2021
20 Roche Diagnostics Operations, Inc. II Nov-17-2020
21 Roche Diagnostics Operations, Inc. II Feb-12-2020
22 Roche Diagnostics Operations, Inc. II Jan-30-2020
23 Siemens Healthcare Diagnostics, Inc. II Apr-18-2019
24 Soft Computer Consultants, Inc. II Jul-20-2021
25 Soft Computer Consultants, Inc. II Jul-19-2021
26 Technidata S.A. II May-10-2023
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