TPLC - Total Product Life Cycle

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Device	system, test, human chorionic gonadotropin
Product Code	DHA
Regulation Number	862.1155
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YHLO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	544	544
High Test Results	294	294
Low Test Results	109	109
Non Reproducible Results	97	97
False Negative Result	63	63
Incorrect, Inadequate or Imprecise Result or Readings	39	39
Incorrect Measurement	19	19
No Apparent Adverse Event	5	5
Output Problem	3	3
High Readings	3	3
Low Readings	3	3
Material Integrity Problem	2	2
Chemical Problem	1	1
Insufficient Information	1	1
Erratic Results	1	1
Unable to Obtain Readings	1	1
Data Problem	1	1
Product Quality Problem	1	1
Failure to Calibrate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	747	747
No Known Impact Or Consequence To Patient	178	178
No Consequences Or Impact To Patient	43	43
Abdominal Pain	19	19
No Information	14	14
Nausea	10	10
Insufficient Information	8	8
Vomiting	7	7
Pain	6	6
No Patient Involvement	5	5
Headache	4	4
Anxiety	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	3	3
Misdiagnosis	3	3
Diarrhea	3	3
Decreased Appetite	2	2
Ectopic Pregnancy	2	2
Lupus	2	2
Test Result	2	2
Cyst(s)	2	2
Intermenstrual Bleeding	2	2
Numbness	2	2
Hallucination	1	1
Decreased Respiratory Rate	1	1
Cough	1	1
Congestive Heart Failure	1	1
Abscess	1	1
Visual Impairment	1	1
Renal Disease, End Stage	1	1
Lymphoma	1	1
Vertigo	1	1
Swelling	1	1
Septic Shock	1	1
Chest Pain	1	1
Weakness	1	1
Fever	1	1
Spinal Column Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Dyskinesia	1	1
Edema	1	1
Anemia	1	1
Complete Induced Abortion	1	1
Memory Loss/Impairment	1	1
Genital Bleeding	1	1
Dysuria	1	1
Sepsis	1	1
Pancreatitis	1	1
Stroke/CVA	1	1
Syncope	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	III	Jan-17-2023
2	Siemens Healthcare Diagnostics, Inc.	II	Apr-28-2022