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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 105 105
2022 166 166
2023 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Missing Information 288 288
Incorrect, Inadequate or Imprecise Result or Readings 163 163
Computer Software Problem 77 77
Patient Data Problem 55 55
Application Program Problem 45 45
Product Quality Problem 29 29
Insufficient Information 22 22
Data Problem 16 16
Adverse Event Without Identified Device or Use Problem 16 16
High Test Results 13 13
Non Reproducible Results 12 12
Low Test Results 11 12
Thermal Decomposition of Device 11 11
False Negative Result 11 11
Installation-Related Problem 11 11
Smoking 10 10
Fail-Safe Problem 10 10
False Positive Result 10 10
Use of Device Problem 10 10
Loss of Data 9 9
Charred 8 8
Mechanical Problem 7 7
No Apparent Adverse Event 7 7
Unintended Movement 6 6
Output Problem 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
Device Fell 3 3
Problem with Software Installation 2 2
Sharp Edges 2 2
Flare or Flash 2 2
Computer System Security Problem 2 2
Detachment of Device or Device Component 2 2
Circuit Failure 2 2
No Device Output 2 2
Application Program Problem: Parameter Calculation Error 2 2
Unable to Obtain Readings 2 2
Failure to Transmit Record 1 1
Failure to Read Input Signal 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Device Issue 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
Melted 1 1
Unintended Collision 1 1
Material Fragmentation 1 1
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
Device Ingredient or Reagent Problem 1 1
Data Back-Up Problem 1 1
Application Security Problem 1 1
Device Inoperable 1 1
Unstable 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Device-Device Incompatibility 1 1
Electrical Shorting 1 1
Device Operates Differently Than Expected 1 1
Application Program Problem: Medication Error 1 1
Misassembly by Users 1 1
Power Problem 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Excessive Heating 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 339 339
No Patient Involvement 326 326
No Known Impact Or Consequence To Patient 104 105
No Consequences Or Impact To Patient 83 83
Insufficient Information 33 33
Laceration(s) 7 7
No Code Available 5 5
Missing Value Reason 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
Abrasion 2 2
Bone Fracture(s) 2 2
Head Injury 1 1
Headache 1 1
Hypoglycemia 1 1
Unspecified Infection 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Erosion 1 1
Congenital Defect/Deformity 1 1
Crushing Injury 1 1
Neonatal Deformities 1 1
Sepsis 1 1
Skin Erosion 1 1
Therapeutic Effects, Unexpected 1 1
Electrolyte Imbalance 1 1
Heart Failure 1 1
Viral Infection 1 1
Neck Pain 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 Jul-06-2023
11 Becton Dickinson & Co. II Apr-29-2022
12 Becton Dickinson & Co. II Mar-23-2019
13 Data Innovations, LLC II Oct-22-2018
14 Inpeco S.A. II May-28-2020
15 Inpeco S.A. II May-26-2020
16 Inpeco S.A. II Oct-31-2018
17 Inpeco S.A. II May-10-2018
18 Normand-Info S.A.S.U. II Jun-08-2021
19 Normand-Info S.A.S.U. II Jul-31-2020
20 Normand-Info S.A.S.U. II Mar-03-2020
21 PerkinElmer Life and Analytical Sciences, Wallac, OY II Apr-27-2018
22 Roche Diabetes Care, Inc. II Apr-26-2022
23 Roche Diagnostics Corporation III Jul-03-2019
24 Roche Diagnostics Corporation II May-17-2019
25 Roche Diagnostics Corporation II Aug-27-2018
26 Roche Diagnostics Operations, Inc. II Jan-12-2023
27 Roche Diagnostics Operations, Inc. II Sep-10-2021
28 Roche Diagnostics Operations, Inc. II Jan-22-2021
29 Roche Diagnostics Operations, Inc. II Nov-17-2020
30 Roche Diagnostics Operations, Inc. II Feb-12-2020
31 Roche Diagnostics Operations, Inc. II Jan-30-2020
32 Siemens Healthcare Diagnostics, Inc. II Apr-18-2019
33 Soft Computer Consultants, Inc. II Jul-20-2021
34 Soft Computer Consultants, Inc. II Jul-19-2021
35 Technidata S.A. II May-10-2023
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