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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
Regulation Description Discrete photometric chemistry analyzer for clinical use.
Product CodeJJE
Regulation Number 862.2160
Device Class 1

MDR Year MDR Reports MDR Events
2020 3984 4453
2021 3920 3920
2022 3999 3999
2023 3795 3796
2024 4238 4238
2025 664 665

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6886 6981
Low Test Results 6352 6484
Non Reproducible Results 4310 4577
Incorrect, Inadequate or Imprecise Result or Readings 3958 3959
False Positive Result 527 527
Incorrect Measurement 465 465
Mechanical Problem 274 274
Output Problem 216 216
Leak/Splash 185 185
False Negative Result 152 152
Smoking 143 143
Insufficient Information 101 101
Use of Device Problem 75 75
No Device Output 73 73
Thermal Decomposition of Device 70 70
Erratic Results 58 58
Unable to Obtain Readings 52 52
Computer Software Problem 51 51
Sparking 51 51
No Apparent Adverse Event 49 49
Low Readings 45 45
Adverse Event Without Identified Device or Use Problem 44 44
High Readings 43 43
Suction Problem 40 40
Appropriate Term/Code Not Available 40 40
Mechanical Jam 30 30
Chemical Problem 30 30
Electrical /Electronic Property Problem 29 29
Optical Problem 28 28
Imprecision 27 27
Material Integrity Problem 26 26
Calibration Problem 25 25
Fluid/Blood Leak 25 25
Electrical Power Problem 25 25
Device Fell 24 24
Infusion or Flow Problem 22 22
Contamination 20 20
Patient Data Problem 19 19
Fire 18 18
Failure to Deliver 18 18
Mechanics Altered 18 18
Unintended Electrical Shock 18 18
Improper or Incorrect Procedure or Method 17 17
Failure to Calibrate 15 15
Pumping Problem 14 14
Filling Problem 14 14
Unintended Movement 14 14
Contamination /Decontamination Problem 14 14
Defective Component 12 12
Degraded 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16271 16285
No Consequences Or Impact To Patient 2089 2089
No Known Impact Or Consequence To Patient 1278 1540
No Patient Involvement 551 551
Insufficient Information 172 298
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
No Code Available 26 26
Test Result 19 88
Hyponatremia 18 18
Exposure to Body Fluids 15 15
Laceration(s) 14 14
Needle Stick/Puncture 11 11
Electrolyte Imbalance 9 9
Abrasion 8 8
Fall 7 7
Electric Shock 5 5
Eye Injury 5 5
Bruise/Contusion 4 4
Bone Fracture(s) 4 4
Pain 4 4
Injury 4 4
Chest Pain 4 4
Damage to Ligament(s) 3 3
Death 3 3
Misdiagnosis 3 3
Muscle/Tendon Damage 3 3
Hypernatremia 3 3
Chemical Exposure 3 3
Conjunctivitis 3 3
Concussion 3 3
Eye Pain 2 2
Cardiac Enzyme Elevation 2 2
Swelling/ Edema 2 2
Renal Failure 2 2
Scar Tissue 2 2
Dehydration 2 2
Unspecified Eye / Vision Problem 2 2
Numbness 2 2
Burn(s) 2 2
Localized Skin Lesion 2 2
Red Eye(s) 2 2
Cramp(s) /Muscle Spasm(s) 1 1
Intermenstrual Bleeding 1 1
Crushing Injury 1 1
Head Injury 1 1
Dry Eye(s) 1 1
Skin Inflammation/ Irritation 1 1
Coma 1 1
Unspecified Kidney or Urinary Problem 1 1
No Information 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 Laboratories II Jan-09-2024
5 Abbott Laboratories II Dec-22-2023
6 Abbott Laboratories II Nov-19-2021
7 Abbott Laboratories II Sep-14-2021
8 Abbott Laboratories, Inc II Apr-06-2020
9 BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. II Feb-25-2025
10 Beckman Coulter Biomedical GmbH II Jul-14-2023
11 Beckman Coulter Biomedical GmbH II Sep-18-2020
12 Beckman Coulter Inc. II Sep-30-2021
13 Beckman Coulter Inc. II Apr-17-2020
14 Beckman Coulter Mishima K.K. II Aug-21-2024
15 Beckman Coulter Mishima K.K. II Jul-31-2024
16 Beckman Coulter, Inc. II Mar-17-2025
17 Beckman Coulter, Inc. II Mar-17-2025
18 Beckman Coulter, Inc. II Mar-17-2025
19 Beckman Coulter, Inc. II Mar-12-2025
20 Beckman Coulter, Inc. II Feb-06-2025
21 Beckman Coulter, Inc. II Oct-07-2024
22 Beckman Coulter, Inc. II Sep-19-2024
23 Beckman Coulter, Inc. II Aug-30-2024
24 Beckman Coulter, Inc. II Aug-27-2024
25 Beckman Coulter, Inc. II Aug-09-2024
26 Beckman Coulter, Inc. II Aug-09-2024
27 Beckman Coulter, Inc. II Jul-23-2024
28 Beckman Coulter, Inc. II Jul-03-2024
29 Beckman Coulter, Inc. II Jun-28-2024
30 Beckman Coulter, Inc. II Feb-05-2024
31 Beckman Coulter, Inc. II Oct-12-2023
32 Beckman Coulter, Inc. II Jul-26-2023
33 Beckman Coulter, Inc. II Mar-15-2023
34 Biomerieux Inc II Mar-02-2020
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, INc. II Jan-21-2025
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 Roche Diagnostics Operations, Inc. II Aug-11-2022
51 Roche Diagnostics Operations, Inc. II May-24-2021
52 Roche Diagnostics Operations, Inc. II Dec-30-2020
53 Roche Diagnostics Operations, Inc. II Dec-29-2020
54 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
55 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
56 Siemens Healthcare Diagnostics, Inc. II Dec-04-2024
57 Siemens Healthcare Diagnostics, Inc. II Nov-20-2024
58 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
59 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
60 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
61 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
62 The Binding Site Group, Ltd. II May-21-2020
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