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TPLC
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Device
calculator, drug dose
Product Code
NDC
Regulation Number
868.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
AL PACHECO AND ASSOCIATES
SUBSTANTIALLY EQUIVALENT
1
COMPANION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
4
GLOOKO, INC
SUBSTANTIALLY EQUIVALENT
1
GNC HOLDINGS, LLC
SUBSTANTIALLY EQUIVALENT
1
HYGIEIA, INC
SUBSTANTIALLY EQUIVALENT
1
MONARCH MEDICAL TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
3
VOLUNTIS, S.A.
SUBSTANTIALLY EQUIVALENT
1
WELLDOC, INC
SUBSTANTIALLY EQUIVALENT
1
WELLDOC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
21
21
2019
18
18
2020
10
10
2021
11
11
2022
348
348
2023
356
356
Device Problems
MDRs with this Device Problem
Events in those MDRs
Wireless Communication Problem
398
398
Computer Software Problem
307
307
Application Program Problem: Dose Calculation Error
36
36
Appropriate Term/Code Not Available
35
35
Break
13
13
Patient Device Interaction Problem
7
7
Insufficient Flow or Under Infusion
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Battery Problem
6
6
Incorrect Software Programming Calculations
5
5
No Apparent Adverse Event
4
4
Patient Data Problem
3
3
Communication or Transmission Problem
3
3
Failure to Align
3
3
Defective Device
2
2
Material Too Rigid or Stiff
2
2
Use of Device Problem
2
2
Fluid/Blood Leak
2
2
Grounding Malfunction
2
2
Connection Problem
2
2
Data Problem
2
2
Priming Problem
1
1
Device Sensing Problem
1
1
Problem with Software Installation
1
1
Unauthorized Access to Computer System
1
1
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Excess Flow or Over-Infusion
1
1
Fracture
1
1
Device Alarm System
1
1
Decoupling
1
1
Improper or Incorrect Procedure or Method
1
1
Product Quality Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
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
689
689
No Consequences Or Impact To Patient
27
27
No Known Impact Or Consequence To Patient
16
16
Hyperglycemia
12
12
Insufficient Information
11
11
Hypoglycemia
7
7
Death
2
2
Cardiac Arrest
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Seizures
1
1
Electrolyte Imbalance
1
1
Ulcer
1
1
Diabetic Ketoacidosis
1
1
Loss of consciousness
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
5
Roche Diabetes Care, Inc.
II
Feb-15-2018
6
Voluntis
II
Nov-17-2018
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