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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 2633 2633

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 5919 6145
Low Test Results 5632 5928
Non Reproducible Results 3458 3985
Incorrect, Inadequate or Imprecise Resultor Readings 3398 3399
Mechanical Problem 782 782
Incorrect Or Inadequate Test Results 606 606
False Positive Result 402 402
Patient Data Problem 376 376
Adverse Event Without Identified Device or Use Problem 370 370
Incorrect Measurement 194 194
Computer Software Problem 150 150
Smoking 140 140
False Negative Result 125 125
Device Issue 120 120
No Apparent Adverse Event 116 116
Leak/Splash 108 108
High Readings 102 102
Low Readings 95 95
Fluid Leak 77 77
Use of Device Problem 74 74
Insufficient Information 70 70
Thermal Decomposition of Device 69 69
No Device Output 67 67
Output Problem 48 48
Device Handling Problem 41 41
Sparking 38 38
Appropriate Term/Code Not Available 37 37
Imprecision 34 34
Power Problem 31 31
Unable to Obtain Readings 29 29
Erratic Results 27 27
Fire 25 25
Electrical /Electronic Property Problem 24 24
Defective Component 22 22
Calibration Problem 20 20
Electrical Power Problem 20 20
Mechanical Jam 19 19
Application Program Problem: Parameter Calculation Error 19 19
Labelling, Instructions for Use or Training Problem 19 19
Overheating of Device 15 15
Unintended Movement 15 15
Device Displays Incorrect Message 13 13
Nonstandard Device 13 13
Charred 13 13
Improper or Incorrect Procedure or Method 11 11
Device Operates Differently Than Expected 11 11
Device Fell 10 10
Unintended Electrical Shock 10 10
Human Factors Issue 9 9
Device Markings/Labelling Problem 9 9
Failure to Calibrate 9 9
Suction Problem 8 8
Melted 8 8
Communication or Transmission Problem 8 8
Human-Device Interface Problem 7 7
Device Operational Issue 7 7
Missing Test Results 6 6
Loose or Intermittent Connection 6 6
Contamination 5 5
Device Emits Odor 5 5
Temperature Problem 5 5
Mechanics Altered 4 4
Data Problem 4 4
Optical Problem 4 4
Device Sensing Problem 4 4
Detachment of Device or Device Component 4 4
Computer Operating System Problem 4 4
Microbial Contamination of Device 4 4
Degraded 4 4
Partial Blockage 4 4
Signal Artifact/Noise 4 4
Fail-Safe Did Not Operate 4 4
Missing Information 4 4
Circuit Failure 3 3
Alarm Not Visible 3 3
Failure to Charge 3 3
Failure to Conduct 3 3
Positioning Failure 3 3
Display or Visual Feedback Problem 3 3
Filling Problem 3 3
Device Contamination with Body Fluid 3 3
Failure to Deliver 3 3
Obstruction of Flow 3 3
Unexpected Therapeutic Results 3 3
Chemical Problem 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Electrical Shorting 3 3
Noise, Audible 3 3
Naturally Worn 3 3
Protective Measures Problem 3 3
Pumping Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Pressure Problem 2 2
Infusion or Flow Problem 2 2
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
Sharp Edges 2 2
Complete Loss of Power 2 2
Malposition of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6494 7299
No Clinical Signs, Symptoms or Conditions 6426 6438
No Consequences Or Impact To Patient 6340 6340
No Patient Involvement 1248 1251
No Code Available 135 135
Insufficient Information 91 217
Injury 32 32
Test Result 30 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Laceration(s) 16 16
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
Electric Shock 8 8
Death 8 8
Misdiagnosis 8 8
Chemical Exposure 5 5
Not Applicable 5 5
Red Eye(s) 4 4
Fall 4 4
Abrasion 4 4
Exposure to Body Fluids 4 4
Bone Fracture(s) 3 3
Pain 3 3
Electrolyte Imbalance 3 3
Unspecified Eye / Vision Problem 2 2
Muscle/Tendon Damage 2 2
Localized Skin Lesion 2 2
Abortion 2 2
Hypernatremia 2 2
Head Injury 2 2
Headache 1 1
Hearing Loss 1 1
Hyperglycemia 1 1
Hypoglycemia 1 1
Dry Eye(s) 1 1
Ectopic Pregnancy 1 1
Fainting 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Conjunctivitis 1 1
Contusion 1 1
Corneal Abrasion 1 1
Hemolytic Anemia 1 1
Induced Abortion 1 1
Dizziness 1 1
Renal Failure 1 1
Scar Tissue 1 1
Seizures 1 1
Shock 1 1
Skin Irritation 1 1
Sprain 1 1
Damage to Ligament(s) 1 1
Nausea 1 1
Overdose 1 1
Hyponatremia 1 1
Unspecified Kidney or Urinary Problem 1 1
Pregnancy 1 1
Eye Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Coma 1 1
Diaphoresis 1 1
Intermenstrual Bleeding 1 1
Alteration In Body Temperature 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 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
37 Ortho Clinical Diagnostics II Aug-24-2020
38 Ortho Clinical Diagnostics II Jul-01-2020
39 Ortho Clinical Diagnostics II Aug-06-2019
40 Ortho-Clinical Diagnostics II Jul-03-2019
41 Ortho-Clinical Diagnostics II May-20-2019
42 Ortho-Clinical Diagnostics II May-06-2019
43 Ortho-Clinical Diagnostics II Apr-25-2019
44 Ortho-Clinical Diagnostics II Dec-20-2018
45 Ortho-Clinical Diagnostics II Dec-14-2017
46 Ortho-Clinical Diagnostics II May-12-2017
47 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
48 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
49 Radiometer America Inc II Oct-01-2018
50 Randox Laboratories II Jun-04-2018
51 Randox Laboratories, Limited II Feb-24-2020
52 Randox Laboratories, Limited II Jul-25-2019
53 Roche Diagnostics Corporation II May-02-2019
54 Roche Diagnostics Corporation II Apr-10-2019
55 Roche Diagnostics Corporation II Jun-10-2018
56 Roche Diagnostics Corporation II Mar-28-2018
57 Roche Diagnostics Corporation II Mar-06-2018
58 Roche Diagnostics Corporation II Feb-21-2018
59 Roche Diagnostics Corporation II Feb-01-2018
60 Roche Diagnostics Corporation II Jan-16-2018
61 Roche Diagnostics Corporation II May-09-2017
62 Roche Diagnostics Operations, Inc. II Aug-11-2022
63 Roche Diagnostics Operations, Inc. II May-24-2021
64 Roche Diagnostics Operations, Inc. II Dec-30-2020
65 Roche Diagnostics Operations, Inc. II Dec-29-2020
66 Roche Diagnostics Operations, Inc. II Sep-05-2019
67 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
68 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
69 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
70 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
71 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
72 Siemens Healthcare Diagnostics, Inc. II Nov-27-2019
73 Siemens Healthcare Diagnostics, Inc. II Oct-24-2019
74 Siemens Healthcare Diagnostics, Inc. II Mar-15-2019
75 Siemens Healthcare Diagnostics, Inc. II Dec-14-2018
76 Siemens Healthcare Diagnostics, Inc. II Nov-09-2018
77 Siemens Healthcare Diagnostics, Inc. II Oct-18-2018
78 Siemens Healthcare Diagnostics, Inc. II May-01-2018
79 Siemens Healthcare Diagnostics, Inc. II Mar-19-2017
80 Siemens Healthcare Diagnostics, Inc. II Feb-23-2017
81 The Binding Site Group, Ltd. II May-21-2020
82 The Binding Site Group, Ltd. II Jan-13-2017
83 bioMerieux, Inc. II Jul-31-2018
84 bioMerieux, Inc. II May-09-2018
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