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TPLC
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Device
bilirubin (total and unbound) in the neonate test system
Product Code
MQM
Regulation Number
862.1113
Device Class
1
Premarket Reviews
Manufacturer
Decision
RADIOMETER MEDICAL APS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2018
5
5
2019
6
6
2020
1
1
2021
1
1
2023
14
14
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Readings
19
19
No Apparent Adverse Event
5
5
Nonstandard Device
3
3
False Negative Result
2
2
Patient Data Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Unexpected Therapeutic Results
2
2
Low Test Results
2
2
Programming Issue
1
1
Fitting Problem
1
1
No Display/Image
1
1
Output Problem
1
1
No Visual Prompts/Feedback
1
1
Image Display Error/Artifact
1
1
Display Difficult to Read
1
1
Non Reproducible Results
1
1
Insufficient Information
1
1
Defective Component
1
1
High Readings
1
1
False Reading From Device Non-Compliance
1
1
No Audible Prompt/Feedback
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Jaundice
20
20
No Clinical Signs, Symptoms or Conditions
8
8
No Known Impact Or Consequence To Patient
5
5
Non specific EKG/ECG Changes
1
1
Neuropathy
1
1
Brain Injury
1
1
No Code Available
1
1
Test Result
1
1
No Information
1
1
Insufficient Information
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical Systems, Inc.
I
Jun-07-2018
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