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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bilirubin (total and unbound) in the neonate test system
Product CodeMQM
Regulation Number 862.1113
Device Class 1


Premarket Reviews
ManufacturerDecision
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 14 14
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 16 16
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 6 6
No Code Available 2 2
Neuropathy 1 1
Test Result 1 1
No Information 1 1
No Consequences Or Impact To Patient 1 1
Brain Injury 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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