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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
2017 110 110
2018 218 218
2019 253 254
2020 52 52
2021 106 106
2022 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Missing Information 288 288
Incorrect, Inadequate or Imprecise Resultor Readings 110 110
Computer Software Problem 51 51
Patient Data Problem 45 45
Application Program Problem 33 33
Adverse Event Without Identified Device or Use Problem 33 33
Insufficient Information 22 22
High Test Results 20 20
Data Problem 15 15
Low Test Results 14 15
Output Problem 14 14
Charred 14 14
Mechanical Problem 12 12
Smoking 12 12
Thermal Decomposition of Device 11 11
Non Reproducible Results 11 11
Use of Device Problem 9 9
Melted 9 9
Loss of Data 9 9
Device Issue 8 8
Device Operational Issue 8 8
Incorrect Or Inadequate Test Results 8 8
Fail-Safe Problem 8 8
No Apparent Adverse Event 7 7
False Negative Result 7 7
Unintended Movement 6 6
False Positive Result 5 5
Device Handling Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Electrical /Electronic Property Problem 4 4
Device Markings/Labelling Problem 3 3
Overheating of Device 3 3
Missing Test Results 3 3
Application Program Version or Upgrade Problem 3 3
Installation-Related Problem 3 3
Mechanical Jam 3 3
Communication or Transmission Problem 2 2
Computer System Security Problem 2 2
Device Operates Differently Than Expected 2 2
Sparking 2 2
Defective Component 2 2
Application Program Problem: Parameter Calculation Error 2 2
Device Fell 2 2
No Device Output 2 2
Detachment of Device or Device Component 2 2
Unable to Obtain Readings 2 2
Failure to Transmit Record 1 1
Application Program Problem: Dose Calculation Error 1 1
Data Back-Up Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Sharp Edges 1 1
Appropriate Term/Code Not Available 1 1
Failure to Align 1 1
Defective Device 1 1
Nonstandard Device 1 1
Crack 1 1
Display or Visual Feedback Problem 1 1
Excessive Heating 1 1
Low Readings 1 1
Arcing 1 1
Device-Device Incompatibility 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Compatibility Problem 1 1
Power Problem 1 1
Product Quality Problem 1 1
Device Inoperable 1 1
Unstable 1 1
Device Contamination with Body Fluid 1 1
Failure to Back-Up 1 1
Contamination 1 1
Leak/Splash 1 1
Application Network Problem 1 1
Date/Time-Related Software Problem 1 1
Fire 1 1
Material Fragmentation 1 1
Visual Prompts will not Clear 1 1
Application Security Problem 1 1
Operating System Version or Upgrade Problem 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
Intermittent Program or Algorithm Execution 1 1
Human-Device Interface Problem 1 1
Application Program Problem: Medication Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 345 345
No Known Impact Or Consequence To Patient 167 168
No Clinical Signs, Symptoms or Conditions 155 155
No Consequences Or Impact To Patient 106 106
Insufficient Information 18 18
Laceration(s) 6 6
No Code Available 6 6
Missing Value Reason 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
Abnormal Blood Gases 1 1
Bone Fracture(s) 1 1
Heart Failure 1 1
Abrasion 1 1
Erosion 1 1
Congenital Defect/Deformity 1 1
Skin Erosion 1 1
Unspecified Heart Problem 1 1
Pneumonia 1 1
Electrolyte Imbalance 1 1
Infection, Indirect 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Suture Abrasion 1 1
Head Injury 1 1
Headache 1 1
Hypoglycemia 1 1
Unspecified Infection 1 1
Neck Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Cancer 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Muscle/Tendon Damage 1 1
Crushing Injury 1 1
Neonatal Deformities 1 1
Sepsis 1 1
Therapeutic Effects, Unexpected 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. III Jan-18-2017
10 Beckman Coulter, Inc. II Aug-11-2021
11 Becton Dickinson & Co. II Apr-29-2022
12 Becton Dickinson & Co. II Mar-23-2019
13 Becton Dickinson & Co. II Feb-27-2017
14 Data Innovations, LLC II Oct-22-2018
15 Data Innovations, LLC II Feb-16-2017
16 Inpeco S.A. II May-28-2020
17 Inpeco S.A. II May-26-2020
18 Inpeco S.A. II Oct-31-2018
19 Inpeco S.A. II May-10-2018
20 Merge Healthcare, Inc. II May-25-2017
21 Normand Informatique II Dec-13-2017
22 Normand-Info S.A.S.U. II Jun-08-2021
23 Normand-Info S.A.S.U. II Jul-31-2020
24 Normand-Info S.A.S.U. II Mar-03-2020
25 PerkinElmer Life and Analytical Sciences, Wallac, OY II Apr-27-2018
26 PerkinElmer Life and Analytical Sciences, Wallac, OY II Mar-13-2017
27 Roche Diabetes Care, Inc. II Apr-26-2022
28 Roche Diagnostics Corporation III Jul-03-2019
29 Roche Diagnostics Corporation II May-17-2019
30 Roche Diagnostics Corporation II Aug-27-2018
31 Roche Diagnostics Corporation II Jun-02-2017
32 Roche Diagnostics Corporation II Mar-23-2017
33 Roche Diagnostics Corporation II Jan-24-2017
34 Roche Diagnostics Operations, Inc. II Sep-10-2021
35 Roche Diagnostics Operations, Inc. II Jan-22-2021
36 Roche Diagnostics Operations, Inc. II Nov-17-2020
37 Roche Diagnostics Operations, Inc. II Feb-12-2020
38 Roche Diagnostics Operations, Inc. II Jan-30-2020
39 Siemens Healthcare Diagnostics, Inc. II Apr-18-2019
40 Siemens Healthcare Diagnostics, Inc. II Feb-15-2017
41 Soft Computer Consultants, Inc. II Jul-20-2021
42 Soft Computer Consultants, Inc. II Jul-19-2021
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