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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay method, troponin subunit
Product CodeMMI
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 5
MITSUBISHI CHEMICAL MEDIENCE CO
  SUBSTANTIALLY EQUIVALENT 1
NANO-DITECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PHC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1150 1150
2015 831 831
2016 487 487
2017 618 618
2018 487 487
2019 521 521
2020 387 387
2021 356 356
2022 507 507
2023 756 756
2024 718 718

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4263 4263
False Positive Result 950 950
Non Reproducible Results 484 484
Incorrect Or Inadequate Test Results 405 405
Incorrect, Inadequate or Imprecise Result or Readings 372 372
Low Test Results 305 305
False Negative Result 228 228
Adverse Event Without Identified Device or Use Problem 162 162
No Apparent Adverse Event 109 109
Incorrect Measurement 52 52
High Readings 48 48
Nonstandard Device 34 34
Device Operates Differently Than Expected 16 16
Device Displays Incorrect Message 14 14
Low Readings 13 13
False Reading From Device Non-Compliance 12 12
Output Problem 11 11
Insufficient Information 11 11
Product Quality Problem 11 11
Air Leak 10 10
False Device Output 8 8
Defective Component 7 7
Failure to Obtain Sample 7 7
Calibration Problem 6 6
Unexpected Therapeutic Results 6 6
Failure to Calibrate 6 6
Unable to Obtain Readings 5 5
Use of Device Problem 5 5
Appropriate Term/Code Not Available 5 5
Material Integrity Problem 4 4
Contamination of Device Ingredient or Reagent 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Calibration Error 2 2
Contamination 2 2
Device Ingredient or Reagent Problem 2 2
Imprecision 2 2
Improper or Incorrect Procedure or Method 2 2
Electrical /Electronic Property Problem 2 2
Device Difficult to Maintain 2 2
Compatibility Problem 2 2
Fluid/Blood Leak 1 1
No Device Output 1 1
Loss of Power 1 1
Device Reprocessing Problem 1 1
Improper Device Output 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Device Contamination With Biological Material 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2465 2465
No Clinical Signs, Symptoms or Conditions 2109 2109
No Consequences Or Impact To Patient 945 945
No Code Available 409 409
Chest Pain 243 243
No Information 213 213
Insufficient Information 59 59
Misdiagnosis 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Pain 37 37
Dizziness 33 33
Test Result 31 31
Myocardial Infarction 29 29
Respiratory Distress 27 27
High Blood Pressure/ Hypertension 23 23
Dyspnea 22 22
Abdominal Pain 18 18
Vomiting 15 15
Congestive Heart Failure 11 11
Weakness 11 11
Chronic Obstructive Pulmonary Disease (COPD) 11 11
Chest Tightness/Pressure 11 11
Nausea 11 11
Fall 9 9
Cardiac Enzyme Elevation 9 9
Headache 8 8
Venipuncture 7 7
Anxiety 7 7
Fatigue 6 6
Heart Failure/Congestive Heart Failure 6 6
Decreased Respiratory Rate 6 6
Ischemic Heart Disease 6 6
Patient Problem/Medical Problem 5 5
Tachycardia 5 5
Pneumonia 5 5
Unspecified Respiratory Problem 5 5
Respiratory Failure 5 5
No Patient Involvement 5 5
Asthma 5 5
Atrial Fibrillation 5 5
Injury 5 5
Fever 5 5
Sore Throat 5 5
Transient Ischemic Attack 5 5
Sepsis 4 4
Renal Failure 4 4
Syncope/Fainting 4 4
Hyperglycemia 4 4
Dehydration 4 4
Hypoxia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Aug-30-2022
2 Abbott Laboratories II May-10-2012
3 Abbott Laboratories II Apr-15-2009
4 Abbott Point Of Care Inc. II Dec-31-2019
5 Abbott Point Of Care Inc. II Aug-22-2012
6 Abbott Point Of Care Inc. II Aug-09-2012
7 Abbott Point Of Care Inc. II Nov-10-2011
8 Abbott Point of Care Canada Limited II Jan-24-2013
9 Alere San Diego II Apr-26-2012
10 Beckman Coulter Inc. II Oct-06-2021
11 Beckman Coulter Inc. II Apr-04-2011
12 Beckman Coulter Inc. II Jul-12-2010
13 Beckman Coulter Inc. II Apr-12-2010
14 Biosite Inc I May-08-2009
15 ORTHO-CLINICAL DIAGNOSTICS II Aug-08-2023
16 QUIDEL CARDIOVASCULAR INC I Jul-07-2023
17 Roche Diagnostics Operations, Inc. II May-14-2021
18 Roche Diagnostics Operations, Inc. I Apr-11-2012
19 Siemens Healthcare Diagnostics Inc II Jul-30-2019
20 Siemens Healthcare Diagnostics Inc II Jan-07-2016
21 Siemens Healthcare Diagnostics, Inc II Jun-21-2016
22 Siemens Healthcare Diagnostics, Inc II Jul-23-2015
23 Siemens Healthcare Diagnostics, Inc II Jul-02-2014
24 Siemens Healthcare Diagnostics, Inc. II Jul-06-2022
25 Siemens Healthcare Diagnostics, Inc. II Oct-02-2020
26 Siemens Healthcare Diagnostics, Inc. II Sep-02-2020
27 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
28 Siemens Healthcare Diagnostics, Inc. II May-04-2018
29 Siemens Healthcare Diagnostics, Inc. II May-05-2017
30 Siemens Healthcare Diagnostics, Inc. II Jun-25-2015
31 Siemens Healthcare Diagnostics, Inc. II Dec-12-2014
32 Siemens Healthcare Diagnostics, Inc. II Mar-18-2011
33 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
34 Siemens Healthcare Diagnostics, Inc. II Sep-11-2010
35 Siemens Healthcare Diagnostics, Inc. II Feb-25-2010
36 Siemens Healthcare Diagnostics, Inc. II Aug-12-2009
37 Tosoh Bioscience Inc II Jun-05-2018
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