TPLC - Total Product Life Cycle

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Device	system, test, automated blood grouping and antibody
Product Code	KSZ
Regulation Number	864.9175
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIO RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	6
DIAGNOSTIC GRIFOLS, S. A.
	SUBSTANTIALLY EQUIVALENT	11
IMMUCOR, INC.
	SUBSTANTIALLY EQUIVALENT	10
MICRO TYPING SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	6
STRATEC BIOMEDICAL UK LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	310	612
Incorrect, Inadequate or Imprecise Result or Readings	192	230
False Positive Result	111	158
Adverse Event Without Identified Device or Use Problem	54	54
Improper or Incorrect Procedure or Method	15	15
Defective Device	15	15
Defective Component	11	11
Computer Software Problem	8	8
Leak/Splash	5	5
Non Reproducible Results	5	13
Alarm Not Visible	4	4
Data Problem	3	3
Device Displays Incorrect Message	3	3
Naturally Worn	3	3
Patient-Device Incompatibility	3	3
Insufficient Information	3	3
Failure to Power Up	2	2
Component Missing	2	2
Contamination	2	2
Failure to Read Input Signal	2	2
Low Readings	2	2
Mechanical Problem	2	4
Output Problem	2	2
Compatibility Problem	1	1
Device Handling Problem	1	1
Use of Device Problem	1	1
Positioning Failure	1	1
Material Twisted/Bent	1	1
Failure to Deliver	1	1
Sparking	1	1
Unintended Electrical Shock	1	1
Circuit Failure	1	1
Image Display Error/Artifact	1	1
Noise, Audible	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Physical Resistance/Sticking	1	1
Coagulation in Device or Device Ingredient	1	1
No Display/Image	1	1
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Protective Measures Problem	1	1
Power Problem	1	1
Break	1	1
Incorrect Measurement	1	1
Device Emits Odor	1	1
No Apparent Adverse Event	1	1
Misassembly During Maintenance/Repair	1	1
Excess Flow or Over-Infusion	1	1
Missing Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	323	477
No Known Impact Or Consequence To Patient	266	282
No Consequences Or Impact To Patient	48	48
Insufficient Information	30	194
Reaction	13	13
Test Result	11	18
Patient Problem/Medical Problem	8	8
Fever	4	4
No Information	3	3
Injury	3	3
No Patient Involvement	3	3
Hemolysis	2	2
No Code Available	2	2
Exposure to Body Fluids	2	2
Hemorrhage/Bleeding	2	2
Non specific EKG/ECG Changes	1	1
High Blood Pressure/ Hypertension	1	1
Electric Shock	1	1
Hyperbilirubinemia	1	1
Respiratory Distress	1	1
Hearing Loss	1	1
Nausea	1	1
Hematuria	1	1
Bone Fracture(s)	1	1
Reaction to Medicinal Component of Device	1	1
Rash	1	1
Chills	1	1
Chest Pain	1	1
Laceration(s)	1	1
Pneumonia	1	1
Tachycardia	1	1
Anxiety	1	1
Unspecified Tissue Injury	1	1
Shaking/Tremors	1	1
Hypoxia	1	1
Headache	1	1
Airway Obstruction	1	1