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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 3785 3786
2024 282 282

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6270 6496
Low Test Results 5649 5946
Non Reproducible Results 4209 4736
Incorrect, Inadequate or Imprecise Result or Readings 3932 3933
False Positive Result 507 507
Incorrect Measurement 328 328
Mechanical Problem 302 302
Leak/Splash 152 152
False Negative Result 146 146
Computer Software Problem 139 139
Smoking 130 130
No Apparent Adverse Event 130 130
Output Problem 117 117
Insufficient Information 87 87
Use of Device Problem 84 84
No Device Output 69 69
Thermal Decomposition of Device 59 59
High Readings 50 50
Erratic Results 50 50
Adverse Event Without Identified Device or Use Problem 46 46
Low Readings 45 45
Sparking 43 43
Unable to Obtain Readings 33 33
Fluid/Blood Leak 32 32
Electrical /Electronic Property Problem 30 30
Appropriate Term/Code Not Available 28 28
Patient Data Problem 28 28
Fire 27 27
Optical Problem 25 25
Electrical Power Problem 24 24
Mechanical Jam 23 23
Defective Component 23 23
Imprecision 21 21
Labelling, Instructions for Use or Training Problem 20 20
Suction Problem 20 20
Calibration Problem 20 20
Device Fell 19 19
Application Program Problem: Parameter Calculation Error 19 19
Contamination 18 18
Unintended Electrical Shock 17 17
Material Integrity Problem 16 16
Improper or Incorrect Procedure or Method 16 16
Power Problem 15 15
Mechanics Altered 14 14
Unintended Movement 14 14
Device Handling Problem 14 14
Chemical Problem 11 11
Contamination /Decontamination Problem 11 11
Failure to Calibrate 11 11
Failure to Deliver 10 10
Overheating of Device 10 10
Infusion or Flow Problem 9 9
Improper Chemical Reaction 9 9
Missing Test Results 8 8
Pumping Problem 8 8
Circuit Failure 8 8
Degraded 8 8
Filling Problem 8 8
Pressure Problem 7 7
Device Displays Incorrect Message 7 7
Temperature Problem 6 6
Signal Artifact/Noise 6 6
Off-Label Use 5 5
Human-Device Interface Problem 5 5
Physical Resistance/Sticking 5 5
Computer Operating System Problem 5 5
Device Sensing Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 4 4
Communication or Transmission Problem 4 4
Microbial Contamination of Device 4 4
Device Contamination with Body Fluid 4 4
Melted 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
Nonstandard Device 3 3
Positioning Failure 3 3
Alarm Not Visible 3 3
Failure to Conduct 3 3
Failure to Charge 3 3
Crack 3 3
Unexpected Therapeutic Results 3 3
Device Markings/Labelling Problem 3 3
Obstruction of Flow 3 3
Application Program Version or Upgrade Problem 3 3
Inadequate User Interface 3 3
Data Problem 3 3
Protective Measures Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Optical Obstruction 2 2
Sharp Edges 2 2
Audible Prompt/Feedback Problem 2 2
Complete Loss of Power 2 2
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Twisted/Bent 2 2
Overfill 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11751 11764
No Consequences Or Impact To Patient 3918 3918
No Known Impact Or Consequence To Patient 3067 3872
No Patient Involvement 736 739
Insufficient Information 116 242
No Code Available 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Test Result 26 95
Laceration(s) 16 16
Injury 16 16
Hyponatremia 15 15
Needle Stick/Puncture 11 11
Premature Labor 11 11
Patient Problem/Medical Problem 8 8
Abrasion 8 8
Exposure to Body Fluids 8 8
Misdiagnosis 7 7
Electric Shock 7 7
No Information 6 17
Death 6 6
Eye Injury 6 6
Electrolyte Imbalance 5 5
Fall 4 4
Bone Fracture(s) 4 4
Bruise/Contusion 4 4
Chest Pain 4 4
Chemical Exposure 4 4
Muscle/Tendon Damage 3 3
Conjunctivitis 3 3
Concussion 3 3
Pain 3 3
Scar Tissue 2 2
Head Injury 2 2
Localized Skin Lesion 2 2
Eye Pain 2 2
Unspecified Eye / Vision Problem 2 2
Hypernatremia 2 2
Missing Value Reason 2 2
Pregnancy 1 1
Full thickness (Third Degree) Burn 1 1
Not Applicable 1 1
Intermenstrual Bleeding 1 1
Alteration In Body Temperature 1 1
Incomplete Induced Abortion 1 1
Unspecified Kidney or Urinary Problem 1 1
Headache 1 1
Hypoglycemia 1 1
Dry Eye(s) 1 1
Non specific EKG/ECG Changes 1 1
Ectopic Pregnancy 1 1
Cardiac Enzyme Elevation 1 1
Contusion 1 1
Corneal Abrasion 1 1
Crushing Injury 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Seizures 1 1
Skin Irritation 1 1
Sprain 1 1
Red Eye(s) 1 1
Renal Failure 1 1
Damage to Ligament(s) 1 1
Abortion 1 1
Numbness 1 1
Coma 1 1
Diaphoresis 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 Dec-13-2023
41 Ortho-Clinical Diagnostics, Inc. II Oct-02-2023
42 Ortho-Clinical Diagnostics, Inc. II May-04-2023
43 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
44 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
45 Randox Laboratories, Limited II Feb-24-2020
46 Randox Laboratories, Limited II Jul-25-2019
47 Roche Diagnostics Corporation II May-02-2019
48 Roche Diagnostics Corporation II Apr-10-2019
49 Roche Diagnostics Operations, Inc. II Aug-11-2022
50 Roche Diagnostics Operations, Inc. II May-24-2021
51 Roche Diagnostics Operations, Inc. II Dec-30-2020
52 Roche Diagnostics Operations, Inc. II Dec-29-2020
53 Roche Diagnostics Operations, Inc. II Sep-05-2019
54 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
55 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
56 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
57 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
58 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
59 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
60 Siemens Healthcare Diagnostics, Inc. II Nov-27-2019
61 Siemens Healthcare Diagnostics, Inc. II Oct-24-2019
62 Siemens Healthcare Diagnostics, Inc. II Mar-15-2019
63 The Binding Site Group, Ltd. II May-21-2020
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