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TPLC
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Device
immunoassay method, troponin subunit
Product Code
MMI
Regulation Number
862.1215
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
3
BECKMAN COULTER INC
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
PHC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
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
2296
2296
Non Reproducible Results
478
478
False Positive Result
452
452
Low Test Results
174
174
Incorrect, Inadequate or Imprecise Result or Readings
114
114
No Apparent Adverse Event
72
72
False Negative Result
60
60
Incorrect Measurement
50
50
High Readings
35
35
Adverse Event Without Identified Device or Use Problem
22
22
Output Problem
11
11
Low Readings
9
9
Insufficient Information
5
5
Mechanical Problem
4
4
Contamination of Device Ingredient or Reagent
4
4
Material Integrity Problem
4
4
Unable to Obtain Readings
4
4
Appropriate Term/Code Not Available
4
4
Unexpected Therapeutic Results
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Use of Device Problem
3
3
Product Quality Problem
2
2
Compatibility Problem
2
2
Device Difficult to Maintain
2
2
Nonstandard Device
2
2
Contamination
1
1
Contamination /Decontamination Problem
1
1
No Device Output
1
1
Device Ingredient or Reagent Problem
1
1
Erratic Results
1
1
Patient-Device Incompatibility
1
1
Device Displays Incorrect Message
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2109
2109
No Known Impact Or Consequence To Patient
399
399
No Consequences Or Impact To Patient
269
269
Chest Pain
122
122
No Code Available
59
59
Insufficient Information
58
58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
40
40
No Information
36
36
Dizziness
23
23
High Blood Pressure/ Hypertension
20
20
Pain
18
18
Myocardial Infarction
15
15
Abdominal Pain
12
12
Respiratory Distress
10
10
Vomiting
9
9
Cardiac Enzyme Elevation
8
8
Nausea
7
7
Decreased Respiratory Rate
6
6
Headache
6
6
Heart Failure/Congestive Heart Failure
6
6
Fall
6
6
Unspecified Respiratory Problem
5
5
Congestive Heart Failure
5
5
Anxiety
5
5
Dyspnea
5
5
Chronic Obstructive Pulmonary Disease (COPD)
5
5
Respiratory Failure
4
4
Dehydration
4
4
Weakness
4
4
Asthma
4
4
Ischemic Heart Disease
4
4
Syncope/Fainting
4
4
Misdiagnosis
3
3
Pneumonia
3
3
Liver Damage/Dysfunction
3
3
Adult Respiratory Distress Syndrome
3
3
Patient Problem/Medical Problem
3
3
Diarrhea
3
3
Fatigue
3
3
Sore Throat
3
3
Respiratory Insufficiency
3
3
Myocarditis
3
3
Stroke/CVA
2
2
Tachycardia
2
2
Cough
2
2
Hyperglycemia
2
2
Hypoxia
2
2
Sepsis
2
2
Vertigo
2
2
Cancer
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Aug-30-2022
2
Abbott Point Of Care Inc.
II
Dec-31-2019
3
Beckman Coulter Inc.
II
Oct-06-2021
4
ORTHO-CLINICAL DIAGNOSTICS
II
Aug-08-2023
5
QUIDEL CARDIOVASCULAR INC
I
Jul-07-2023
6
Roche Diagnostics Operations, Inc.
II
May-14-2021
7
Siemens Healthcare Diagnostics Inc
II
Jul-30-2019
8
Siemens Healthcare Diagnostics, Inc.
II
Jul-06-2022
9
Siemens Healthcare Diagnostics, Inc.
II
Oct-02-2020
10
Siemens Healthcare Diagnostics, Inc.
II
Sep-02-2020
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