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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
2018 218 218
2019 253 254
2020 52 52
2021 106 106
2022 169 169
2023 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Missing Information 288 288
Incorrect, Inadequate or Imprecise Result or Readings 143 143
Computer Software Problem 66 66
Patient Data Problem 47 47
Application Program Problem 39 39
Insufficient Information 22 22
Product Quality Problem 20 20
Adverse Event Without Identified Device or Use Problem 16 16
Data Problem 15 15
Non Reproducible Results 12 12
High Test Results 11 11
Low Test Results 11 12
Smoking 10 10
Use of Device Problem 10 10
Fail-Safe Problem 10 10
Loss of Data 9 9
Thermal Decomposition of Device 9 9
Charred 8 8
Installation-Related Problem 8 8
Mechanical Problem 7 7
False Negative Result 6 6
False Positive Result 6 6
No Apparent Adverse Event 6 6
Output Problem 5 5
Unintended Movement 5 5
Device Handling Problem 4 4
Application Program Version or Upgrade Problem 4 4
Overheating of Device 4 4
Improper or Incorrect Procedure or Method 4 4
Leak/Splash 3 3
Electrical /Electronic Property Problem 3 3
Communication or Transmission Problem 3 3
Device Markings/Labelling Problem 3 3
Device Operational Issue 3 3
Missing Test Results 3 3
Incorrect Or Inadequate Test Results 3 3
Mechanical Jam 3 3
Sharp Edges 2 2
Device Fell 2 2
Computer System Security Problem 2 2
Detachment of Device or Device Component 2 2
Unable to Obtain Readings 2 2
No Device Output 2 2
Application Program Problem: Parameter Calculation Error 2 2
Material Fragmentation 1 1
Melted 1 1
Failure to Back-Up 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Display or Visual Feedback Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Device Issue 1 1
Device Inoperable 1 1
Unstable 1 1
Low Readings 1 1
Failure to Align 1 1
Date/Time-Related Software Problem 1 1
Arcing 1 1
Defective Device 1 1
Sparking 1 1
Application Network Problem 1 1
Failure to Transmit Record 1 1
Application Security Problem 1 1
Device Ingredient or Reagent Problem 1 1
Data Back-Up Problem 1 1
Device-Device Incompatibility 1 1
Electrical Shorting 1 1
Device Operates Differently Than Expected 1 1
Flare or Flash 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Application Program Problem: Medication Error 1 1
Mechanics Altered 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Power Problem 1 1
Excessive Heating 1 1
Intermittent Program or Algorithm Execution 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 326 326
No Clinical Signs, Symptoms or Conditions 261 261
No Known Impact Or Consequence To Patient 104 105
No Consequences Or Impact To Patient 83 83
Insufficient Information 28 28
Laceration(s) 6 6
No Code Available 5 5
Missing Value Reason 2 2
No Information 2 2
Patient Problem/Medical Problem 2 2
Abrasion 2 2
Bone Fracture(s) 2 2
Head Injury 1 1
Headache 1 1
Hypoglycemia 1 1
Unspecified Infection 1 1
Exposure to Body Fluids 1 1
Erosion 1 1
Congenital Defect/Deformity 1 1
Crushing Injury 1 1
Heart Failure 1 1
Neck Pain 1 1
Neonatal Deformities 1 1
Sepsis 1 1
Skin Erosion 1 1
Therapeutic Effects, Unexpected 1 1
Electrolyte Imbalance 1 1
Abnormal Blood Gases 1 1
Partial thickness (Second Degree) Burn 1 1
Cancer 1 1
Unspecified Heart Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Muscle/Tendon Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Sep-26-2019
2 Abbott Point Of Care Inc. II Mar-08-2018
3 Beckman Coulter Inc. II Aug-23-2021
4 Beckman Coulter Inc. II Nov-18-2019
5 Beckman Coulter Inc. II Jul-17-2019
6 Beckman Coulter Inc. III Oct-31-2018
7 Beckman Coulter Inc. II Mar-22-2018
8 Beckman Coulter Inc. II Mar-21-2018
9 Beckman Coulter, Inc. II Aug-11-2021
10 Becton Dickinson & Co. II Apr-29-2022
11 Becton Dickinson & Co. II Mar-23-2019
12 Data Innovations, LLC II Oct-22-2018
13 Inpeco S.A. II May-28-2020
14 Inpeco S.A. II May-26-2020
15 Inpeco S.A. II Oct-31-2018
16 Inpeco S.A. II May-10-2018
17 Normand-Info S.A.S.U. II Jun-08-2021
18 Normand-Info S.A.S.U. II Jul-31-2020
19 Normand-Info S.A.S.U. II Mar-03-2020
20 PerkinElmer Life and Analytical Sciences, Wallac, OY II Apr-27-2018
21 Roche Diabetes Care, Inc. II Apr-26-2022
22 Roche Diagnostics Corporation III Jul-03-2019
23 Roche Diagnostics Corporation II May-17-2019
24 Roche Diagnostics Corporation II Aug-27-2018
25 Roche Diagnostics Operations, Inc. II Jan-12-2023
26 Roche Diagnostics Operations, Inc. II Sep-10-2021
27 Roche Diagnostics Operations, Inc. II Jan-22-2021
28 Roche Diagnostics Operations, Inc. II Nov-17-2020
29 Roche Diagnostics Operations, Inc. II Feb-12-2020
30 Roche Diagnostics Operations, Inc. II Jan-30-2020
31 Siemens Healthcare Diagnostics, Inc. II Apr-18-2019
32 Soft Computer Consultants, Inc. II Jul-20-2021
33 Soft Computer Consultants, Inc. II Jul-19-2021
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