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TPLC
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Device
calculator, drug dose
Regulation Description
Predictive pulmonary-function value calculator.
Product Code
NDC
Regulation Number
868.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMALGAM RX, INC
SUBSTANTIALLY EQUIVALENT
1
COMPANION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
GNC HOLDINGS, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC MINIMED
SUBSTANTIALLY EQUIVALENT
1
MONARCH MEDICAL TECHNOLOGIES
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
2020
10
10
2021
11
11
2022
348
348
2023
462
462
2024
168
168
2025
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Wireless Communication Problem
599
599
Computer Software Problem
384
384
Appropriate Term/Code Not Available
53
53
Break
18
18
Patient Device Interaction Problem
14
14
Application Program Problem: Dose Calculation Error
10
10
Insufficient Flow or Under Infusion
9
9
Battery Problem
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Material Too Rigid or Stiff
4
4
No Apparent Adverse Event
4
4
Communication or Transmission Problem
3
3
Unauthorized Access to Computer System
3
3
Failure to Align
3
3
Priming Problem
2
2
Defective Device
2
2
Grounding Malfunction
2
2
Fluid/Blood Leak
2
2
Device Sensing Problem
1
1
Connection Problem
1
1
Problem with Software Installation
1
1
Inaccurate Delivery
1
1
Product Quality Problem
1
1
Device Alarm System
1
1
Excess Flow or Over-Infusion
1
1
Obstruction of Flow
1
1
Application Network Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Application Program Version or Upgrade Problem
1
1
Use of Device Problem
1
1
Fracture
1
1
Application Program Problem
1
1
Patient Data Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
970
970
Hyperglycemia
15
15
Insufficient Information
11
11
Hypoglycemia
6
6
No Consequences Or Impact To Patient
5
5
No Known Impact Or Consequence To Patient
3
3
Diabetic Ketoacidosis
2
2
Death
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Ulcer
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Companion Medical, Inc.
II
Dec-20-2022
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