TPLC - Total Product Life Cycle

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Device	insulin pump secondary display
Definition	The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Product Code	PKU
Regulation Number	862.1350
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	15137	15138
Computer Software Problem	8518	8518
Appropriate Term/Code Not Available	1468	1468
Communication or Transmission Problem	1083	1083
Application Network Problem	113	113
Problem with Software Installation	44	44
Device Alarm System	42	42
No Apparent Adverse Event	36	36
Unauthorized Access to Computer System	7	7
Adverse Event Without Identified Device or Use Problem	4	4
Application Program Problem	3	3
Data Problem	3	3
Break	2	2
Power Problem	2	2
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Battery Problem	1	1
Moisture or Humidity Problem	1	1
Erratic or Intermittent Display	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22212	22213
Insufficient Information	516	516
Hyperglycemia	87	87
Hypoglycemia	65	65
Discomfort	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hemorrhage/Bleeding	5	5
Diabetic Ketoacidosis	4	4
Bruise/Contusion	4	4
Confusion/ Disorientation	3	3
Itching Sensation	2	2
Loss of consciousness	2	2
Abdominal Pain	1	1
Skin Infection	1	1
Nausea	1	1
Hematoma	1	1
Vomiting	1	1
Dyspnea	1	1
Anxiety	1	1
Shaking/Tremors	1	1
Hypoglycemic Shock	1	1
Joint Contracture	1	1
Headache	1	1