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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
  1.  K183375  Yumizen C1200, Yumizen C1200 Glucose HK, Sodium El ...

MDR Year MDR Reports MDR Events
2019 3947 4504
2020 3984 4453
2021 3920 3920
2022 3999 3999
2023 3793 3794
2024 951 951

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6495 6721
Low Test Results 5866 6163
Non Reproducible Results 4362 4889
Incorrect, Inadequate or Imprecise Result or Readings 4037 4038
False Positive Result 528 528
Incorrect Measurement 352 352
Mechanical Problem 313 313
Leak/Splash 160 160
False Negative Result 146 146
Smoking 140 140
Computer Software Problem 139 139
Output Problem 132 132
No Apparent Adverse Event 131 131
Insufficient Information 90 90
Use of Device Problem 85 85
No Device Output 70 70
Thermal Decomposition of Device 63 63
Erratic Results 51 51
High Readings 50 50
Adverse Event Without Identified Device or Use Problem 46 46
Sparking 45 45
Low Readings 45 45
Unable to Obtain Readings 38 38
Appropriate Term/Code Not Available 35 35
Fluid/Blood Leak 34 34
Electrical /Electronic Property Problem 30 30
Defective Component 28 28
Patient Data Problem 28 28
Fire 27 27
Optical Problem 26 26
Mechanical Jam 25 25
Electrical Power Problem 25 25
Suction Problem 22 22
Imprecision 21 21
Calibration Problem 21 21
Material Integrity Problem 20 20
Labelling, Instructions for Use or Training Problem 20 20
Application Program Problem: Parameter Calculation Error 19 19
Device Fell 19 19
Contamination 18 18
Unintended Electrical Shock 17 17
Improper or Incorrect Procedure or Method 16 16
Device Handling Problem 15 15
Mechanics Altered 15 15
Power Problem 15 15
Unintended Movement 14 14
Chemical Problem 13 13
Failure to Deliver 12 12
Failure to Calibrate 12 12
Infusion or Flow Problem 12 12
Contamination /Decontamination Problem 11 11
Overheating of Device 10 10
Degraded 9 9
Filling Problem 9 9
Improper Chemical Reaction 9 9
Pumping Problem 9 9
Missing Test Results 8 8
Circuit Failure 8 8
Signal Artifact/Noise 7 7
Pressure Problem 7 7
Device Displays Incorrect Message 7 7
Temperature Problem 6 6
Off-Label Use 6 6
Melted 5 5
Physical Resistance/Sticking 5 5
Computer Operating System Problem 5 5
Human-Device Interface 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
Data Problem 4 4
Microbial Contamination of Device 4 4
Device Contamination with Body Fluid 4 4
Fail-Safe Did Not Operate 4 4
Missing Information 4 4
Program or Algorithm Execution Problem 4 4
Program or Algorithm Execution Failure 4 4
Suction Failure 4 4
Protective Measures Problem 3 3
Unexpected Therapeutic Results 3 3
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
Therapeutic or Diagnostic Output Failure 3 3
Obstruction of Flow 3 3
Inadequate User Interface 3 3
Application Program Version or Upgrade Problem 3 3
Device Markings/Labelling Problem 3 3
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Overfill 2 2
Application Program Problem 2 2
Optical Obstruction 2 2
Material Twisted/Bent 2 2
Sharp Edges 2 2
Audible Prompt/Feedback Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12411 12424
No Consequences Or Impact To Patient 3918 3918
No Known Impact Or Consequence To Patient 3067 3872
No Patient Involvement 736 739
Insufficient Information 122 248
No Code Available 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Test Result 26 95
Injury 16 16
Laceration(s) 16 16
Hyponatremia 15 15
Needle Stick/Puncture 11 11
Premature Labor 11 11
Exposure to Body Fluids 10 10
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
No Information 6 17
Fall 5 5
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
Hypernatremia 2 2
Scar Tissue 2 2
Burn(s) 2 2
Head Injury 2 2
Localized Skin Lesion 2 2
Missing Value Reason 2 2
Eye Pain 2 2
Unspecified Eye / Vision Problem 2 2
Pregnancy 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
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

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, Limited II Feb-24-2020
49 Randox Laboratories, Limited II Jul-25-2019
50 Roche Diagnostics Corporation II May-02-2019
51 Roche Diagnostics Corporation II Apr-10-2019
52 Roche Diagnostics Operations, Inc. II Aug-11-2022
53 Roche Diagnostics Operations, Inc. II May-24-2021
54 Roche Diagnostics Operations, Inc. II Dec-30-2020
55 Roche Diagnostics Operations, Inc. II Dec-29-2020
56 Roche Diagnostics Operations, Inc. II Sep-05-2019
57 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
58 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
59 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
60 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
61 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
62 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
63 Siemens Healthcare Diagnostics, Inc. II Nov-27-2019
64 Siemens Healthcare Diagnostics, Inc. II Oct-24-2019
65 Siemens Healthcare Diagnostics, Inc. II Mar-15-2019
66 The Binding Site Group, Ltd. II May-21-2020
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