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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
DRAEGER MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
RADIOMETER MEDICAL APS
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
1
1
2018
5
5
2019
6
6
2020
1
1
2021
1
1
2023
14
14
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Readings
12
12
Nonstandard Device
3
3
Low Test Results
2
2
False Negative Result
2
2
False Reading From Device Non-Compliance
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Unexpected Therapeutic Results
2
2
Patient Data Problem
2
2
Non Reproducible Results
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Defective Component
1
1
Image Display Error/Artifact
1
1
Display Difficult to Read
1
1
No Display/Image
1
1
High Readings
1
1
Unable to Obtain Readings
1
1
Output Problem
1
1
Programming Issue
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Jaundice
14
14
No Clinical Signs, Symptoms or Conditions
7
7
No Known Impact Or Consequence To Patient
6
6
No Code Available
2
2
Brain Injury
1
1
No Consequences Or Impact To Patient
1
1
Test Result
1
1
Neuropathy
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical Systems, Inc.
I
Jun-07-2018
2
Siemens Healthcare Diagnostics Inc
II
Mar-06-2015
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