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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

MDR Year MDR Reports MDR Events
2018 5 5
2019 6 6
2020 1 1
2021 1 1
2023 14 14
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 11 11
Nonstandard Device 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Unexpected Therapeutic Results 2 2
False Negative Result 2 2
Patient Data Problem 2 2
Non Reproducible Results 1 1
False Reading From Device Non-Compliance 1 1
Image Display Error/Artifact 1 1
Output Problem 1 1
Programming Issue 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Defective Component 1 1
Low Test Results 1 1
High Readings 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Jaundice 13 13
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 4 4
Test Result 1 1
No Information 1 1
No Code Available 1 1
Neuropathy 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
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