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TPLC
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show TPLC since
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Device
calculator, drug dose
Product Code
NDC
Regulation Number
868.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
COMPANION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
GNC HOLDINGS, LLC
SUBSTANTIALLY EQUIVALENT
1
HYGIEIA, INC
SUBSTANTIALLY EQUIVALENT
1
MONARCH MEDICAL TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
3
VOLUNTIS SA.
SUBSTANTIALLY EQUIVALENT
1
VOLUNTIS, S.A.
SUBSTANTIALLY EQUIVALENT
1
WELLDOC, INC
SUBSTANTIALLY EQUIVALENT
1
WELLDOC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
18
18
2020
10
10
2021
11
11
2022
348
348
2023
462
462
2024
82
82
Device Problems
MDRs with this Device Problem
Events in those MDRs
Wireless Communication Problem
539
539
Computer Software Problem
355
355
Appropriate Term/Code Not Available
48
48
Application Program Problem: Dose Calculation Error
23
23
Break
16
16
Patient Device Interaction Problem
10
10
Insufficient Flow or Under Infusion
8
8
Battery Problem
6
6
Adverse Event Without Identified Device or Use Problem
4
4
No Apparent Adverse Event
4
4
Unauthorized Access to Computer System
3
3
Communication or Transmission Problem
3
3
Material Too Rigid or Stiff
3
3
Failure to Align
3
3
Defective Device
2
2
Use of Device Problem
2
2
Fluid/Blood Leak
2
2
Grounding Malfunction
2
2
Connection Problem
2
2
Patient Data Problem
2
2
Priming Problem
1
1
Data Problem
1
1
Device Sensing Problem
1
1
Problem with Software Installation
1
1
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Excess Flow or Over-Infusion
1
1
Product Quality Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Alarm System
1
1
Decoupling
1
1
Fracture
1
1
Improper or Incorrect Procedure or Method
1
1
Application Program Problem
1
1
Application Program Version or Upgrade Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
876
876
No Consequences Or Impact To Patient
17
17
Hyperglycemia
12
12
Insufficient Information
11
11
No Known Impact Or Consequence To Patient
8
8
Hypoglycemia
5
5
Ulcer
1
1
Diabetic Ketoacidosis
1
1
Death
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Companion Medical, Inc.
II
Dec-20-2022
2
Monarch Medical Technologies
II
Nov-08-2019
3
Monarch Medical Technologies
II
Jun-15-2019
4
Roche Diabetes Care, Inc.
II
Sep-26-2019
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