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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

MDR Year MDR Reports MDR Events
2020 3984 4453
2021 3920 3920
2022 3999 3999
2023 3795 3796
2024 4202 4202

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6656 6751
Low Test Results 6127 6259
Non Reproducible Results 4134 4400
Incorrect, Inadequate or Imprecise Result or Readings 3854 3855
False Positive Result 499 499
Incorrect Measurement 447 447
Mechanical Problem 258 258
Output Problem 200 200
Leak/Splash 180 180
False Negative Result 146 146
Smoking 135 135
Insufficient Information 96 96
Use of Device Problem 74 74
No Device Output 72 72
Thermal Decomposition of Device 69 69
Erratic Results 58 58
Sparking 51 51
Unable to Obtain Readings 50 50
Computer Software Problem 47 47
Low Readings 44 44
No Apparent Adverse Event 44 44
Adverse Event Without Identified Device or Use Problem 43 43
High Readings 43 43
Appropriate Term/Code Not Available 38 38
Suction Problem 35 35
Mechanical Jam 30 30
Chemical Problem 29 29
Electrical /Electronic Property Problem 28 28
Optical Problem 28 28
Imprecision 25 25
Electrical Power Problem 25 25
Fluid/Blood Leak 25 25
Calibration Problem 24 24
Material Integrity Problem 24 24
Device Fell 24 24
Infusion or Flow Problem 21 21
Contamination 19 19
Patient Data Problem 19 19
Fire 18 18
Mechanics Altered 17 17
Failure to Deliver 17 17
Unintended Electrical Shock 17 17
Improper or Incorrect Procedure or Method 15 15
Contamination /Decontamination Problem 14 14
Unintended Movement 14 14
Filling Problem 14 14
Failure to Calibrate 14 14
Pumping Problem 13 13
Defective Component 12 12
Degraded 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15598 15611
No Consequences Or Impact To Patient 2089 2089
No Known Impact Or Consequence To Patient 1278 1540
No Patient Involvement 551 551
Insufficient Information 150 276
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
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 10 10
Electrolyte Imbalance 9 9
Abrasion 8 8
Fall 7 7
Eye Injury 5 5
Electric Shock 5 5
Bruise/Contusion 4 4
Pain 4 4
Bone Fracture(s) 4 4
Chest Pain 4 4
Injury 4 4
Damage to Ligament(s) 3 3
Muscle/Tendon Damage 3 3
Hypernatremia 3 3
Concussion 3 3
Conjunctivitis 3 3
Death 3 3
Chemical Exposure 3 3
Misdiagnosis 3 3
Burn(s) 2 2
Localized Skin Lesion 2 2
Unspecified Eye / Vision Problem 2 2
Dehydration 2 2
Scar Tissue 2 2
Red Eye(s) 2 2
Renal Failure 2 2
Swelling/ Edema 2 2
Cardiac Enzyme Elevation 2 2
Eye Pain 2 2
Ectopic Pregnancy 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Intermenstrual Bleeding 1 1
Crushing Injury 1 1
Head Injury 1 1
Patient Problem/Medical Problem 1 1
Incomplete Induced Abortion 1 1
Numbness 1 1
Dry Eye(s) 1 1
Non specific EKG/ECG Changes 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 Biomedical GmbH II Jul-14-2023
10 Beckman Coulter Biomedical GmbH II Sep-18-2020
11 Beckman Coulter Inc. II Sep-30-2021
12 Beckman Coulter Inc. II Apr-17-2020
13 Beckman Coulter Mishima K.K. II Aug-21-2024
14 Beckman Coulter Mishima K.K. II Jul-31-2024
15 Beckman Coulter, Inc. II Oct-07-2024
16 Beckman Coulter, Inc. II Sep-19-2024
17 Beckman Coulter, Inc. II Aug-30-2024
18 Beckman Coulter, Inc. II Aug-27-2024
19 Beckman Coulter, Inc. II Aug-09-2024
20 Beckman Coulter, Inc. II Aug-09-2024
21 Beckman Coulter, Inc. II Jul-23-2024
22 Beckman Coulter, Inc. II Jul-03-2024
23 Beckman Coulter, Inc. II Jun-28-2024
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 Biomerieux Inc II Mar-02-2020
29 Inpeco S.A. II May-05-2020
30 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
31 Ortho Clinical Diagnostics II Aug-24-2020
32 Ortho Clinical Diagnostics II Jul-01-2020
33 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
34 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
35 Ortho-Clinical Diagnostics, Inc. II Mar-01-2024
36 Ortho-Clinical Diagnostics, Inc. II Dec-13-2023
37 Ortho-Clinical Diagnostics, Inc. II Oct-02-2023
38 Ortho-Clinical Diagnostics, Inc. II May-04-2023
39 Ortho-Clinical Diagnostics, Inc. II Sep-02-2022
40 Ortho-Clinical Diagnostics, Inc. II Jan-07-2021
41 Randox Laboratories Ltd. III May-09-2024
42 Randox Laboratories, Limited II Feb-24-2020
43 Roche Diagnostics Operations, Inc. II Aug-11-2022
44 Roche Diagnostics Operations, Inc. II May-24-2021
45 Roche Diagnostics Operations, Inc. II Dec-30-2020
46 Roche Diagnostics Operations, Inc. II Dec-29-2020
47 Siemens Healthcare Diagnostics Inc. II Jun-29-2020
48 Siemens Healthcare Diagnostics, Inc II Oct-16-2021
49 Siemens Healthcare Diagnostics, Inc. II Dec-04-2024
50 Siemens Healthcare Diagnostics, Inc. II Nov-20-2024
51 Siemens Healthcare Diagnostics, Inc. II Jul-05-2023
52 Siemens Healthcare Diagnostics, Inc. II Dec-02-2021
53 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
54 Siemens Healthcare Diagnostics, Inc. II Jun-19-2020
55 The Binding Site Group, Ltd. II May-21-2020
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