TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2423	2423
Non Reproducible Results	524	524
False Positive Result	467	467
Low Test Results	189	189
Incorrect, Inadequate or Imprecise Result or Readings	116	116
No Apparent Adverse Event	72	72
False Negative Result	60	60
Incorrect Measurement	51	51
High Readings	35	35
Adverse Event Without Identified Device or Use Problem	23	23
Output Problem	13	13
Low Readings	9	9
Mechanical Problem	5	5
Insufficient Information	5	5
Material Integrity Problem	4	4
Unable to Obtain Readings	4	4
Contamination of Device Ingredient or Reagent	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
Compatibility Problem	2	2
Device Difficult to Maintain	2	2
Product Quality Problem	2	2
Nonstandard Device	2	2
Signal Artifact/Noise	1	1
Device Ingredient or Reagent Problem	1	1
Patient-Device Incompatibility	1	1
Erratic Results	1	1
Contamination	1	1
Contamination /Decontamination Problem	1	1
Device Displays Incorrect Message	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2250	2250
No Known Impact Or Consequence To Patient	399	399
No Consequences Or Impact To Patient	269	269
Chest Pain	130	130
Insufficient Information	65	65
No Code Available	59	59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
No Information	36	36
Dizziness	24	24
High Blood Pressure/ Hypertension	22	22
Pain	18	18
Myocardial Infarction	16	16
Abdominal Pain	12	12
Respiratory Distress	10	10
Vomiting	9	9
Decreased Respiratory Rate	8	8
Cardiac Enzyme Elevation	8	8
Nausea	7	7
Dyspnea	6	6
Fall	6	6
Headache	6	6
Heart Failure/Congestive Heart Failure	6	6
Chronic Obstructive Pulmonary Disease (COPD)	5	5
Unspecified Respiratory Problem	5	5
Pneumonia	5	5
Anxiety	5	5
Congestive Heart Failure	5	5
Weakness	4	4
Asthma	4	4
Dehydration	4	4
Ischemic Heart Disease	4	4
Respiratory Failure	4	4
Syncope/Fainting	4	4
Misdiagnosis	3	3
Cough	3	3
Fatigue	3	3
Adult Respiratory Distress Syndrome	3	3
Sore Throat	3	3
Respiratory Insufficiency	3	3
Atrial Fibrillation	3	3
Liver Damage/Dysfunction	3	3
Diarrhea	3	3
Myocarditis	3	3
Patient Problem/Medical Problem	3	3
Tachycardia	2	2
Hypoxia	2	2
Hyperglycemia	2	2
Cancer	2	2
Vertigo	2	2
Pulmonary Embolism	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