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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


Premarket Reviews
ManufacturerDecision
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 85 85
2015 142 142
2016 204 204
2017 110 110
2018 218 218
2019 253 254
2020 52 52
2021 105 105
2022 166 166
2023 173 173
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Missing Information 288 288
Incorrect, Inadequate or Imprecise Result or Readings 209 209
Computer Software Problem 121 121
Patient Data Problem 99 99
Use of Device Problem 77 77
Application Program Problem 67 67
Output Problem 57 57
Adverse Event Without Identified Device or Use Problem 54 54
Data Problem 54 54
Product Quality Problem 41 41
High Test Results 40 40
Device Operational Issue 40 40
Device Operates Differently Than Expected 36 36
Problem with Software Installation 35 35
Charred 33 33
Insufficient Information 27 27
Improper or Incorrect Procedure or Method 26 26
Smoking 25 25
Incorrect Or Inadequate Test Results 25 25
Low Test Results 24 25
Nonstandard Device 23 23
Thermal Decomposition of Device 19 19
False Negative Result 18 18
Mechanical Problem 14 14
Device Issue 13 13
Non Reproducible Results 13 13
Installation-Related Problem 11 11
Programming Issue 11 11
Melted 11 11
Overheating of Device 11 11
False Positive Result 11 11
Loss of Data 10 10
Fail-Safe Problem 10 10
Device Handling Problem 10 10
Application Program Problem: Dose Calculation Error 9 9
Device Markings/Labelling Problem 8 8
No Apparent Adverse Event 8 8
Unintended Movement 8 8
Appropriate Term/Code Not Available 6 6
Application Program Problem: Medication Error 6 6
Human Factors Issue 6 6
Communication or Transmission Problem 6 6
Computer Operating System Problem 5 5
Incorrect Software Programming Calculations 5 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Use of Incorrect Control/Treatment Settings 5 5
Display or Visual Feedback Problem 5 5
Human-Device Interface Problem 5 5
Mechanical Jam 5 5
Crack 4 4
Electrical /Electronic Property Problem 4 4
Application Program Version or Upgrade Problem 4 4
Device Displays Incorrect Message 4 4
Sparking 3 3
Unable to Obtain Readings 3 3
Detachment Of Device Component 3 3
Display Difficult to Read 3 3
Leak/Splash 3 3
Precipitate in Device or Device Ingredient 3 3
Unintended Collision 3 3
Missing Test Results 3 3
Device Fell 3 3
Sharp Edges 2 2
Flare or Flash 2 2
Misassembly by Users 2 2
Protective Measures Problem 2 2
Operating System Version or Upgrade Problem 2 2
Device Emits Odor 2 2
No Device Output 2 2
Application Program Problem: Parameter Calculation Error 2 2
Excess Flow or Over-Infusion 2 2
Fire 2 2
Circuit Failure 2 2
Failure to Transmit Record 2 2
Device Inoperable 2 2
Defective Component 2 2
Device Contamination with Body Fluid 2 2
Detachment of Device or Device Component 2 2
Computer System Security Problem 2 2
Connection Problem 2 2
Data Back-Up Problem 1 1
Device Ingredient or Reagent Problem 1 1
Implant Mobility NOS (Not otherwise specified) 1 1
Application Network Problem 1 1
Application Security Problem 1 1
Battery Problem 1 1
Charging Problem 1 1
Contamination /Decontamination Problem 1 1
Inaccurate Delivery 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
Failure to Read Input Signal 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Failure to Back-Up 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 416 416
No Patient Involvement 395 395
No Known Impact Or Consequence To Patient 357 358
No Consequences Or Impact To Patient 253 253
Insufficient Information 37 37
Laceration(s) 15 15
No Information 11 11
No Code Available 7 7
Patient Problem/Medical Problem 5 5
Misdiagnosis 5 5
Injury 3 3
Hyperglycemia 3 3
Hypoglycemia 3 3
Asthma 3 3
Bone Fracture(s) 3 3
Abrasion 2 2
Headache 2 2
Exposure to Body Fluids 2 2
Overdose 2 2
Concussion 2 2
Missing Value Reason 2 2
Cancer 1 1
Unspecified Heart Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Muscle/Tendon Damage 1 1
Electrolyte Imbalance 1 1
Numbness 1 1
Obstruction/Occlusion 1 1
Neck Pain 1 1
Needle Stick/Puncture 1 1
Suture Abrasion 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Electric Shock 1 1
Missed Dose 1 1
Abnormal Blood Gases 1 1
Partial thickness (Second Degree) Burn 1 1
Pain 1 1
Pneumonia 1 1
Sepsis 1 1
Skin Erosion 1 1
Therapeutic Effects, Unexpected 1 1
Heart Failure 1 1
Infection, Indirect 1 1
Viral Infection 1 1
Complaint, Ill-Defined 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Liver Laceration(s) 1 1
Nausea 1 1
Neonatal Deformities 1 1
Erosion 1 1
Bruise/Contusion 1 1
Cardiopulmonary Arrest 1 1
Congenital Defect/Deformity 1 1
Crushing Injury 1 1
Cardiac Enzyme Elevation 1 1
Hematoma 1 1
Hemolysis 1 1
Hemorrhage/Bleeding 1 1
Adhesion(s) 1 1
Arrhythmia 1 1
Head Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Sep-26-2019
2 Abbott Laboratories, Inc II Sep-18-2009
3 Abbott Laboratories, Inc II Feb-05-2009
4 Abbott Point Of Care Inc. II Mar-08-2018
5 Abbott Point of Care Inc. II Feb-26-2010
6 Beckman Coulter Inc II Jun-25-2015
7 Beckman Coulter Inc. II Aug-23-2021
8 Beckman Coulter Inc. II Nov-18-2019
9 Beckman Coulter Inc. II Jul-17-2019
10 Beckman Coulter Inc. III Oct-31-2018
11 Beckman Coulter Inc. II Mar-22-2018
12 Beckman Coulter Inc. II Mar-21-2018
13 Beckman Coulter Inc. III Jan-18-2017
14 Beckman Coulter, Inc. II Aug-11-2021
15 Becton Dickinson & Co. II Jul-06-2023
16 Becton Dickinson & Co. II Apr-29-2022
17 Becton Dickinson & Co. II Mar-23-2019
18 Becton Dickinson & Co. II Feb-27-2017
19 Cerner Corp II May-01-2009
20 Data Innovations, Inc. II Dec-24-2013
21 Data Innovations, Inc. II Oct-21-2011
22 Data Innovations, LLC II Oct-22-2018
23 Data Innovations, LLC II Feb-16-2017
24 Data Innovations, LLC II Sep-12-2014
25 GE Healthcare Integrated IT Solutions II May-15-2009
26 GE Healthcare It II Aug-26-2016
27 GE Healthcare It III Jan-29-2014
28 GE Healthcare It II Jan-02-2014
29 GE Healthcare It II Nov-15-2013
30 GE Healthcare It II Jun-24-2013
31 Ge Healthcare It III Jun-26-2015
32 Ge Healthcare It II Jun-14-2011
33 Ge Healthcare It II Feb-15-2011
34 Ge Healthcare It II Oct-22-2010
35 Horiba Instruments, Inc dba Horiba Medical II Mar-11-2014
36 Horiba Instruments, Inc dba Horiba Medical III Apr-03-2013
37 Horiba Instruments, Inc dba Horiba Medical II Jan-07-2013
38 Inpeco S.A. II May-28-2020
39 Inpeco S.A. II May-26-2020
40 Inpeco S.A. II Oct-31-2018
41 Inpeco S.A. II May-10-2018
42 International Technidyne Corporation III Sep-20-2010
43 McKesson Technologies, Inc. II Jul-27-2015
44 Medical Information Technology, Inc. II Mar-19-2014
45 Medical Information Technology, Inc. II Mar-03-2014
46 Medical Information Technology, Inc. II Apr-26-2012
47 Merge Healthcare, Inc. II May-25-2017
48 Merge Healthcare, Inc. II Nov-11-2016
49 Microsoft Corporation Health Solutions Group III Jun-04-2012
50 Microsoft Corporation Health Solutions Group II Mar-08-2012
51 Microsoft Corporation Health Solutions Group II Feb-22-2012
52 Microsoft Corporation Health Solutions Group II Jan-11-2012
53 Normand Informatique II Dec-13-2017
54 Normand-Info S.A.S.U. II Jun-08-2021
55 Normand-Info S.A.S.U. II Jul-31-2020
56 Normand-Info S.A.S.U. II Mar-03-2020
57 Perkin Elmer II Aug-25-2009
58 Perkin Elmer Life Sciences Inc II Oct-26-2015
59 PerkinElmer Health Sciences, Inc. II Dec-23-2016
60 PerkinElmer Health Sciences, Inc. II Aug-07-2014
61 PerkinElmer Life and Analytical Sciences, Wallac, OY II Apr-27-2018
62 PerkinElmer Life and Analytical Sciences, Wallac, OY II Mar-13-2017
63 Radiometer America Inc II Sep-06-2014
64 Roche Diabetes Care, Inc. II Apr-26-2022
65 Roche Diabetes Care, Inc. II Apr-02-2015
66 Roche Diagnostics Corp. II May-20-2009
67 Roche Diagnostics Corporation III Jul-03-2019
68 Roche Diagnostics Corporation II May-17-2019
69 Roche Diagnostics Corporation II Aug-27-2018
70 Roche Diagnostics Corporation II Jun-02-2017
71 Roche Diagnostics Corporation II Mar-23-2017
72 Roche Diagnostics Corporation II Jan-24-2017
73 Roche Diagnostics Operations, Inc. II Jan-12-2023
74 Roche Diagnostics Operations, Inc. II Sep-10-2021
75 Roche Diagnostics Operations, Inc. II Jan-22-2021
76 Roche Diagnostics Operations, Inc. II Nov-17-2020
77 Roche Diagnostics Operations, Inc. II Feb-12-2020
78 Roche Diagnostics Operations, Inc. II Jan-30-2020
79 Roche Diagnostics Operations, Inc. II Oct-25-2016
80 Roche Diagnostics Operations, Inc. II Mar-23-2016
81 Roche Diagnostics Operations, Inc. II Nov-18-2015
82 Roche Diagnostics Operations, Inc. II Sep-01-2014
83 SCC Soft Computer II Feb-09-2015
84 SCC Soft Computer II Feb-02-2015
85 SCC Soft Computer II May-09-2014
86 SCC Soft Computer II Aug-03-2012
87 SCC Soft Computer II Jan-11-2012
88 SCC Soft Computer II Jan-11-2012
89 SCC Soft Computer III Jan-11-2012
90 SCC Soft Computer II Dec-02-2011
91 SCC Soft Computer II Nov-21-2011
92 SCC Soft Computer II Nov-17-2011
93 SCC Soft Computer II Nov-16-2010
94 SCC Soft Computer II Nov-15-2010
95 SCC Soft Computer II Nov-10-2010
96 Siemens Healthcare Diagnostics Inc III Jul-17-2014
97 Siemens Healthcare Diagnostics, Inc. II Apr-18-2019
98 Siemens Healthcare Diagnostics, Inc. II Feb-15-2017
99 Siemens Healthcare Diagnostics, Inc. II Jul-02-2015
100 Siemens Healthcare Diagnostics, Inc. II Jun-30-2015
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