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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
2018 4587 4587
2019 3947 4504
2020 3984 4453
2021 3929 3929
2022 4021 4021

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 5998 6224
Low Test Results 5500 5796
Non Reproducible Results 3862 4389
Incorrect, Inadequate or Imprecise Result or Readings 3548 3549
Mechanical Problem 527 527
False Positive Result 421 421
Patient Data Problem 367 367
Incorrect Or Inadequate Test Results 358 358
Incorrect Measurement 234 234
Adverse Event Without Identified Device or Use Problem 215 215
Computer Software Problem 150 150
False Negative Result 131 131
Smoking 127 127
No Apparent Adverse Event 120 120
Leak/Splash 116 116
High Readings 104 104
Low Readings 98 98
Device Issue 86 86
Use of Device Problem 78 78
No Device Output 67 67
Thermal Decomposition of Device 66 66
Insufficient Information 60 60
Output Problem 59 59
Fluid/Blood Leak 40 40
Erratic Results 38 38
Device Handling Problem 36 36
Imprecision 35 35
Unable to Obtain Readings 34 34
Appropriate Term/Code Not Available 32 32
Sparking 32 32
Fire 26 26
Defective Component 24 24
Electrical /Electronic Property Problem 23 23
Calibration Problem 22 22
Electrical Power Problem 22 22
Power Problem 22 22
Mechanical Jam 20 20
Labelling, Instructions for Use or Training Problem 20 20
Application Program Problem: Parameter Calculation Error 19 19
Overheating of Device 14 14
Unintended Movement 14 14
Nonstandard Device 13 13
Device Fell 11 11
Unintended Electrical Shock 11 11
Optical Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Contamination 10 10
Suction Problem 9 9
Failure to Calibrate 9 9
Communication or Transmission Problem 8 8
Device Displays Incorrect Message 8 8
Human Factors Issue 8 8
Mechanics Altered 6 6
Device Operational Issue 6 6
Infusion or Flow Problem 6 6
Device Markings/Labelling Problem 6 6
Chemical Problem 6 6
Pumping Problem 6 6
Missing Test Results 6 6
Melted 6 6
Loose or Intermittent Connection 6 6
Degraded 5 5
Temperature Problem 5 5
Computer Operating System Problem 5 5
Device Sensing Problem 5 5
Human-Device Interface Problem 5 5
Material Integrity Problem 4 4
Detachment of Device or Device Component 4 4
Failure to Deliver 4 4
Obstruction of Flow 4 4
Data Problem 4 4
Physical Resistance/Sticking 4 4
Partial Blockage 4 4
Signal Artifact/Noise 4 4
Charred 4 4
Circuit Failure 4 4
Microbial Contamination of Device 4 4
Fail-Safe Did Not Operate 4 4
Missing Information 4 4
Device Contamination with Body Fluid 3 3
Device Emits Odor 3 3
Off-Label Use 3 3
Unexpected Therapeutic Results 3 3
Failure to Conduct 3 3
Alarm Not Visible 3 3
Failure to Charge 3 3
Positioning Failure 3 3
Filling Problem 3 3
Noise, Audible 3 3
Program or Algorithm Execution Failure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 3 3
Contamination /Decontamination Problem 3 3
Device Operates Differently Than Expected 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Improper Chemical Reaction 3 3
Malposition of Device 2 2
Naturally Worn 2 2
Pressure Problem 2 2
Intermittent Communication Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7795 7807
No Consequences Or Impact To Patient 5757 5757
No Known Impact Or Consequence To Patient 5327 6132
No Patient Involvement 1163 1166
No Code Available 124 124
Insufficient Information 96 222
Test Result 29 98
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Injury 22 22
Laceration(s) 14 14
Patient Problem/Medical Problem 12 12
Missing Value Reason 12 12
Premature Labor 11 11
Needle Stick/Puncture 10 10
No Information 8 19
Misdiagnosis 8 8
Death 8 8
Eye Injury 7 7
Electric Shock 7 7
Exposure to Body Fluids 5 5
Abrasion 4 4
Fall 4 4
Bone Fracture(s) 4 4
Chemical Exposure 4 4
Muscle/Tendon Damage 3 3
Electrolyte Imbalance 3 3
Pain 3 3
Red Eye(s) 2 2
Head Injury 2 2
Abortion 2 2
Conjunctivitis 2 2
Localized Skin Lesion 2 2
Eye Pain 2 2
Unspecified Eye / Vision Problem 2 2
Hypernatremia 2 2
Not Applicable 2 2
Full thickness (Third Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Hemolytic Anemia 1 1
Coma 1 1
Diaphoresis 1 1
Intermenstrual Bleeding 1 1
Alteration In Body Temperature 1 1
Hyponatremia 1 1
Unspecified Kidney or Urinary Problem 1 1
Pregnancy 1 1
Contusion 1 1
Corneal Abrasion 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Headache 1 1
Hyperglycemia 1 1
Hypoglycemia 1 1
Dry Eye(s) 1 1
Ectopic Pregnancy 1 1
Cardiac Enzyme Elevation 1 1
Renal Failure 1 1
Scar Tissue 1 1
Seizures 1 1
Shock 1 1
Skin Irritation 1 1
Sprain 1 1
Incomplete Induced Abortion 1 1
Induced Abortion 1 1
Fainting 1 1
Damage to Ligament(s) 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 Alere San Diego, Inc. II Sep-05-2019
18 Beckman Coulter Biomedical GmbH II Sep-18-2020
19 Beckman Coulter Inc. II Sep-30-2021
20 Beckman Coulter Inc. II Apr-17-2020
21 Beckman Coulter Inc. II Mar-30-2019
22 Beckman Coulter Inc. II Oct-11-2018
23 Beckman Coulter Inc. III Jan-03-2018
24 Bio-Rad Laboratories Inc II Jul-25-2018
25 Bio-Rad Laboratories, Inc II Jun-30-2019
26 Biomerieux Inc II Mar-02-2020
27 ELITech Group B.V. III Sep-30-2019
28 Horiba Instruments, Inc dba Horiba Medical II Jan-31-2018
29 Inova Diagnostics Incorporated II Mar-27-2018
30 Inpeco S.A. II May-05-2020
31 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
32 Ortho Clinical Diagnostics II Aug-24-2020
33 Ortho Clinical Diagnostics II Jul-01-2020
34 Ortho Clinical Diagnostics II Aug-06-2019
35 Ortho-Clinical Diagnostics II Jul-03-2019
36 Ortho-Clinical Diagnostics II May-20-2019
37 Ortho-Clinical Diagnostics II May-06-2019
38 Ortho-Clinical Diagnostics II Apr-25-2019
39 Ortho-Clinical Diagnostics II Dec-20-2018
40 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
41 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
42 Radiometer America Inc II Oct-01-2018
43 Randox Laboratories II Jun-04-2018
44 Randox Laboratories, Limited II Feb-24-2020
45 Randox Laboratories, Limited II Jul-25-2019
46 Roche Diagnostics Corporation II May-02-2019
47 Roche Diagnostics Corporation II Apr-10-2019
48 Roche Diagnostics Corporation II Jun-10-2018
49 Roche Diagnostics Corporation II Mar-28-2018
50 Roche Diagnostics Corporation II Mar-06-2018
51 Roche Diagnostics Corporation II Feb-21-2018
52 Roche Diagnostics Corporation II Feb-01-2018
53 Roche Diagnostics Corporation II Jan-16-2018
54 Roche Diagnostics Operations, Inc. II Aug-11-2022
55 Roche Diagnostics Operations, Inc. II May-24-2021
56 Roche Diagnostics Operations, Inc. II Dec-30-2020
57 Roche Diagnostics Operations, Inc. II Dec-29-2020
58 Roche Diagnostics Operations, Inc. II Sep-05-2019
59 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
60 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
61 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
62 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
63 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
64 Siemens Healthcare Diagnostics, Inc. II Nov-27-2019
65 Siemens Healthcare Diagnostics, Inc. II Oct-24-2019
66 Siemens Healthcare Diagnostics, Inc. II Mar-15-2019
67 Siemens Healthcare Diagnostics, Inc. II Dec-14-2018
68 Siemens Healthcare Diagnostics, Inc. II Nov-09-2018
69 Siemens Healthcare Diagnostics, Inc. II Oct-18-2018
70 Siemens Healthcare Diagnostics, Inc. II May-01-2018
71 The Binding Site Group, Ltd. II May-21-2020
72 bioMerieux, Inc. II Jul-31-2018
73 bioMerieux, Inc. II May-09-2018
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