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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
2019 3947 4504
2020 3984 4453
2021 3920 3920
2022 3999 3999
2023 3795 3796
2024 1672 1672

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6776 7002
Low Test Results 6075 6372
Non Reproducible Results 4514 5041
Incorrect, Inadequate or Imprecise Result or Readings 4141 4142
False Positive Result 541 541
Incorrect Measurement 378 378
Mechanical Problem 329 329
Leak/Splash 171 171
False Negative Result 149 149
Output Problem 146 146
Computer Software Problem 141 141
Smoking 141 141
No Apparent Adverse Event 138 138
Insufficient Information 92 92
Use of Device Problem 88 88
No Device Output 70 70
Thermal Decomposition of Device 65 65
Erratic Results 53 53
High Readings 51 51
Adverse Event Without Identified Device or Use Problem 48 48
Sparking 48 48
Low Readings 46 46
Unable to Obtain Readings 42 42
Appropriate Term/Code Not Available 41 41
Fluid/Blood Leak 35 35
Electrical /Electronic Property Problem 31 31
Defective Component 28 28
Patient Data Problem 28 28
Fire 27 27
Optical Problem 26 26
Mechanical Jam 26 26
Electrical Power Problem 25 25
Suction Problem 25 25
Calibration Problem 23 23
Device Fell 22 22
Material Integrity Problem 21 21
Imprecision 21 21
Labelling, Instructions for Use or Training Problem 20 20
Chemical Problem 20 20
Application Program Problem: Parameter Calculation Error 19 19
Contamination 18 18
Unintended Electrical Shock 18 18
Mechanics Altered 16 16
Improper or Incorrect Procedure or Method 16 16
Power Problem 15 15
Device Handling Problem 15 15
Unintended Movement 14 14
Infusion or Flow Problem 14 14
Failure to Deliver 13 13
Failure to Calibrate 12 12
Contamination /Decontamination Problem 12 12
Overheating of Device 11 11
Degraded 10 10
Filling Problem 9 9
Circuit Failure 9 9
Improper Chemical Reaction 9 9
Pumping Problem 9 9
Missing Test Results 8 8
Signal Artifact/Noise 8 8
Pressure Problem 7 7
Device Displays Incorrect Message 7 7
Temperature Problem 6 6
Physical Resistance/Sticking 6 6
Off-Label Use 6 6
Melted 5 5
Communication or Transmission Problem 5 5
Computer Operating System Problem 5 5
Device Sensing Problem 5 5
Human-Device Interface Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 4 4
Data Problem 4 4
Crack 4 4
Microbial Contamination of Device 4 4
Device Contamination with Body Fluid 4 4
Missing Information 4 4
Fail-Safe Did Not Operate 4 4
Program or Algorithm Execution Problem 4 4
Program or Algorithm Execution Failure 4 4
Suction Failure 4 4
Unexpected Therapeutic Results 3 3
Failure to Charge 3 3
Failure to Conduct 3 3
Alarm Not Visible 3 3
Nonstandard Device 3 3
Positioning Failure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 3 3
Application Program Version or Upgrade Problem 3 3
Device Markings/Labelling Problem 3 3
Obstruction of Flow 3 3
Inadequate User Interface 3 3
Compatibility Problem 2 2
Improper Flow or Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Overfill 2 2
Application Program Problem 2 2
Naturally Worn 2 2
Material Twisted/Bent 2 2
Optical Obstruction 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13122 13135
No Consequences Or Impact To Patient 3918 3918
No Known Impact Or Consequence To Patient 3067 3872
No Patient Involvement 736 739
Insufficient Information 124 250
No Code Available 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 46
Test Result 26 95
Laceration(s) 17 17
Injury 16 16
Hyponatremia 15 15
Needle Stick/Puncture 11 11
Premature Labor 11 11
Exposure to Body Fluids 11 11
Abrasion 9 9
Electrolyte Imbalance 9 9
Patient Problem/Medical Problem 8 8
Electric Shock 7 7
Misdiagnosis 7 7
Death 6 6
Eye Injury 6 6
Fall 6 6
No Information 6 17
Chemical Exposure 5 5
Bone Fracture(s) 4 4
Bruise/Contusion 4 4
Chest Pain 4 4
Conjunctivitis 3 3
Concussion 3 3
Pain 3 3
Muscle/Tendon Damage 3 3
Localized Skin Lesion 2 2
Missing Value Reason 2 2
Eye Pain 2 2
Unspecified Eye / Vision Problem 2 2
Hypernatremia 2 2
Scar Tissue 2 2
Burn(s) 2 2
Head Injury 2 2
Headache 1 1
Hypoglycemia 1 1
Dehydration 1 1
Dry Eye(s) 1 1
Non specific EKG/ECG Changes 1 1
Ectopic Pregnancy 1 1
Cardiac Enzyme Elevation 1 1
Cardiac Arrest 1 1
Contusion 1 1
Corneal Abrasion 1 1
Crushing Injury 1 1
Seizures 1 1
Skin Irritation 1 1
Sprain 1 1
Abortion 1 1
Damage to Ligament(s) 1 1
Incomplete Induced Abortion 1 1
Red Eye(s) 1 1
Renal Failure 1 1
Pregnancy 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Unspecified Kidney or Urinary Problem 1 1
Numbness 1 1
Coma 1 1
Diaphoresis 1 1
Intermenstrual Bleeding 1 1
Alteration In Body Temperature 1 1
Full thickness (Third Degree) Burn 1 1
Not Applicable 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 Jan-09-2024
13 Abbott Laboratories II Dec-22-2023
14 Abbott Laboratories II Nov-19-2021
15 Abbott Laboratories II Sep-14-2021
16 Abbott Laboratories, Inc II Apr-06-2020
17 Abbott Laboratories, Inc II Apr-08-2019
18 Alere San Diego, Inc. II Sep-05-2019
19 Beckman Coulter Biomedical GmbH II Jul-14-2023
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 Feb-05-2024
25 Beckman Coulter, Inc. II Oct-12-2023
26 Beckman Coulter, Inc. II Jul-26-2023
27 Beckman Coulter, Inc. II Mar-15-2023
28 Bio-Rad Laboratories, Inc II Jun-30-2019
29 Biomerieux Inc II Mar-02-2020
30 ELITech Group B.V. III Sep-30-2019
31 Inpeco S.A. II May-05-2020
32 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
33 Ortho Clinical Diagnostics II Aug-24-2020
34 Ortho Clinical Diagnostics II Jul-01-2020
35 Ortho Clinical Diagnostics II Aug-06-2019
36 Ortho-Clinical Diagnostics II Jul-03-2019
37 Ortho-Clinical Diagnostics II May-20-2019
38 Ortho-Clinical Diagnostics II May-06-2019
39 Ortho-Clinical Diagnostics II Apr-25-2019
40 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
41 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
42 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
43 Ortho-Clinical Diagnostics, Inc. II Dec-13-2023
44 Ortho-Clinical Diagnostics, Inc. II Oct-02-2023
45 Ortho-Clinical Diagnostics, Inc. II May-04-2023
46 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
47 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
48 Randox Laboratories Ltd. III May-09-2024
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 Operations, Inc. II Aug-11-2022
54 Roche Diagnostics Operations, Inc. II May-24-2021
55 Roche Diagnostics Operations, Inc. II Dec-30-2020
56 Roche Diagnostics Operations, Inc. II Dec-29-2020
57 Roche Diagnostics Operations, Inc. II Sep-05-2019
58 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
59 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
60 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
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 The Binding Site Group, Ltd. II May-21-2020
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