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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, chemistry (photometric, discrete), for clinical use
Product CodeJJE
Regulation Number 862.2160
Device Class 1


Premarket Reviews
ManufacturerDecision
HORIBA, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1868 1868
2018 4587 4587
2019 3947 4504
2020 3984 4453
2021 3929 3929
2022 1237 1237

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 5464 5690
Low Test Results 5186 5482
Incorrect, Inadequate or Imprecise Resultor Readings 3173 3174
Non Reproducible Results 3117 3644
Mechanical Problem 760 760
Incorrect Or Inadequate Test Results 606 606
Patient Data Problem 374 374
Adverse Event Without Identified Device or Use Problem 368 368
False Positive Result 368 368
Incorrect Measurement 157 157
Computer Software Problem 148 148
Smoking 130 130
Device Issue 120 120
False Negative Result 117 117
No Apparent Adverse Event 111 111
High Readings 99 99
Leak/Splash 98 98
Low Readings 91 91
Fluid Leak 75 75
Use of Device Problem 69 69
Thermal Decomposition of Device 67 67
No Device Output 65 65
Insufficient Information 49 49
Device Handling Problem 41 41
Output Problem 40 40
Appropriate Term/Code Not Available 36 36
Sparking 34 34
Imprecision 33 33
Power Problem 30 30
Unable to Obtain Readings 28 28
Fire 23 23
Defective Component 22 22
Electrical /Electronic Property Problem 21 21
Labelling, Instructions for Use or Training Problem 19 19
Application Program Problem: Parameter Calculation Error 19 19
Electrical Power Problem 18 18
Mechanical Jam 17 17
Erratic Results 17 17
Calibration Problem 14 14
Unintended Movement 14 14
Overheating of Device 14 14
Charred 13 13
Device Displays Incorrect Message 13 13
Nonstandard Device 12 12
Improper or Incorrect Procedure or Method 11 11
Device Operates Differently Than Expected 11 11
Human Factors Issue 9 9
Device Markings/Labelling Problem 9 9
Unintended Electrical Shock 9 9
Communication or Transmission Problem 8 8
Human-Device Interface Problem 7 7
Device Operational Issue 7 7
Device Fell 7 7
Failure to Calibrate 7 7
Melted 7 7
Loose or Intermittent Connection 6 6
Missing Test Results 6 6
Contamination 5 5
Device Emits Odor 5 5
Suction Problem 5 5
Microbial Contamination of Device 4 4
Partial Blockage 4 4
Signal Artifact/Noise 4 4
Data Problem 4 4
Temperature Problem 4 4
Device Sensing Problem 4 4
Mechanics Altered 4 4
Computer Operating System Problem 4 4
Missing Information 4 4
Fail-Safe Did Not Operate 3 3
Detachment of Device or Device Component 3 3
Electrical Shorting 3 3
Protective Measures Problem 3 3
Noise, Audible 3 3
Circuit Failure 3 3
Alarm Not Visible 3 3
Failure to Charge 3 3
Degraded 3 3
Positioning Failure 3 3
Display or Visual Feedback Problem 3 3
Device Contamination with Body Fluid 3 3
Obstruction of Flow 3 3
Unexpected Therapeutic Results 3 3
Overfill 2 2
Failure to Deliver 2 2
Unintended System Motion 2 2
Loss of Power 2 2
Off-Label Use 2 2
Crack 2 2
Device Maintenance Issue 2 2
Failure to Conduct 2 2
Component Falling 2 2
Burst Container or Vessel 2 2
Complete Loss of Power 2 2
Sharp Edges 2 2
Program or Algorithm Execution Problem 2 2
Program or Algorithm Execution Failure 2 2
Intermittent Communication Failure 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6494 7299
No Consequences Or Impact To Patient 6340 6340
No Clinical Signs, Symptoms or Conditions 5054 5066
No Patient Involvement 1248 1251
No Code Available 135 135
Insufficient Information 77 203
Injury 32 32
Test Result 30 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Laceration(s) 14 14
Needle Stick/Puncture 13 13
Premature Labor 12 12
Patient Problem/Medical Problem 12 12
Missing Value Reason 12 12
Eye Injury 10 10
No Information 9 20
Death 8 8
Misdiagnosis 8 8
Electric Shock 7 7
Chemical Exposure 5 5
Not Applicable 5 5
Fall 4 4
Abrasion 4 4
Exposure to Body Fluids 3 3
Pain 3 3
Red Eye(s) 3 3
Bone Fracture(s) 3 3
Electrolyte Imbalance 3 3
Abortion 2 2
Hypernatremia 2 2
Head Injury 2 2
Unspecified Eye / Vision Problem 2 2
Localized Skin Lesion 2 2
Pregnancy 1 1
Hyponatremia 1 1
Unspecified Kidney or Urinary Problem 1 1
Muscle/Tendon Damage 1 1
Full thickness (Third Degree) Burn 1 1
Intermenstrual Bleeding 1 1
Alteration In Body Temperature 1 1
Partial thickness (Second Degree) Burn 1 1
Headache 1 1
Hearing Loss 1 1
Hyperglycemia 1 1
Hypoglycemia 1 1
Dizziness 1 1
Nausea 1 1
Overdose 1 1
Hemolytic Anemia 1 1
Coma 1 1
Diaphoresis 1 1
Induced Abortion 1 1
Renal Failure 1 1
Scar Tissue 1 1
Seizures 1 1
Shock 1 1
Skin Irritation 1 1
Sprain 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Contusion 1 1
Corneal Abrasion 1 1
Dry Eye(s) 1 1
Ectopic Pregnancy 1 1
Fainting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Gmbh & Co. KG II Jul-24-2020
2 Abbott Gmbh & Co. KG II Jun-18-2020
3 Abbott Gmbh & Co. KG II Mar-26-2020
4 Abbott Gmbh & Co. KG II Nov-22-2019
5 Abbott Gmbh & Co. KG II Aug-24-2019
6 Abbott Gmbh & Co. KG II Aug-06-2019
7 Abbott Gmbh & Co. KG II Jun-02-2019
8 Abbott Gmbh & Co. KG II May-30-2019
9 Abbott Gmbh & Co. KG II May-13-2019
10 Abbott Gmbh & Co. KG II Apr-18-2019
11 Abbott Gmbh & Co. KG II Jan-30-2019
12 Abbott Laboratories II Nov-19-2021
13 Abbott Laboratories II Sep-14-2021
14 Abbott Laboratories, Inc II Apr-06-2020
15 Abbott Laboratories, Inc II Apr-08-2019
16 Abbott Laboratories, Inc II Jan-18-2018
17 Abbott Laboratories, Inc II Nov-21-2017
18 Abbott Laboratories, Inc II Oct-06-2017
19 Alere San Diego, Inc. II Sep-05-2019
20 Beckman Coulter Biomedical GmbH II Sep-18-2020
21 Beckman Coulter Inc. II Sep-30-2021
22 Beckman Coulter Inc. II Apr-17-2020
23 Beckman Coulter Inc. II Mar-30-2019
24 Beckman Coulter Inc. II Oct-11-2018
25 Beckman Coulter Inc. III Jan-03-2018
26 Beckman Coulter Inc. II Oct-24-2017
27 Beckman Coulter Inc. II Apr-03-2017
28 Beckman Coulter Inc. II Mar-15-2017
29 Bio-Rad Laboratories Inc II Jul-25-2018
30 Bio-Rad Laboratories, Inc II Jun-30-2019
31 Biomerieux Inc II Mar-02-2020
32 ELITech Group B.V. III Sep-30-2019
33 Horiba Instruments, Inc dba Horiba Medical II Jan-31-2018
34 Inova Diagnostics Incorporated II Mar-27-2018
35 Inpeco S.A. II May-05-2020
36 Ortho Clinical Diagnostics II Aug-24-2020
37 Ortho Clinical Diagnostics II Jul-01-2020
38 Ortho Clinical Diagnostics II Aug-06-2019
39 Ortho-Clinical Diagnostics II Jul-03-2019
40 Ortho-Clinical Diagnostics II May-20-2019
41 Ortho-Clinical Diagnostics II May-06-2019
42 Ortho-Clinical Diagnostics II Apr-25-2019
43 Ortho-Clinical Diagnostics II Dec-20-2018
44 Ortho-Clinical Diagnostics II Dec-14-2017
45 Ortho-Clinical Diagnostics II May-12-2017
46 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
47 Radiometer America Inc II Oct-01-2018
48 Randox Laboratories II Jun-04-2018
49 Randox Laboratories, Limited II Feb-24-2020
50 Randox Laboratories, Limited II Jul-25-2019
51 Roche Diagnostics Corporation II May-02-2019
52 Roche Diagnostics Corporation II Apr-10-2019
53 Roche Diagnostics Corporation II Jun-10-2018
54 Roche Diagnostics Corporation II Mar-28-2018
55 Roche Diagnostics Corporation II Mar-06-2018
56 Roche Diagnostics Corporation II Feb-21-2018
57 Roche Diagnostics Corporation II Feb-01-2018
58 Roche Diagnostics Corporation II Jan-16-2018
59 Roche Diagnostics Corporation II May-09-2017
60 Roche Diagnostics Operations, Inc. II May-24-2021
61 Roche Diagnostics Operations, Inc. II Dec-30-2020
62 Roche Diagnostics Operations, Inc. II Dec-29-2020
63 Roche Diagnostics Operations, Inc. II Sep-05-2019
64 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
65 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
66 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
67 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
68 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
69 Siemens Healthcare Diagnostics, Inc. II Nov-27-2019
70 Siemens Healthcare Diagnostics, Inc. II Oct-24-2019
71 Siemens Healthcare Diagnostics, Inc. II Mar-15-2019
72 Siemens Healthcare Diagnostics, Inc. II Dec-14-2018
73 Siemens Healthcare Diagnostics, Inc. II Nov-09-2018
74 Siemens Healthcare Diagnostics, Inc. II Oct-18-2018
75 Siemens Healthcare Diagnostics, Inc. II May-01-2018
76 Siemens Healthcare Diagnostics, Inc. II Mar-19-2017
77 Siemens Healthcare Diagnostics, Inc. II Feb-23-2017
78 The Binding Site Group, Ltd. II May-21-2020
79 The Binding Site Group, Ltd. II Jan-13-2017
80 bioMerieux, Inc. II Jul-31-2018
81 bioMerieux, Inc. II May-09-2018
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