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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
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Product CodeMQM
Regulation Number 862.1113
Device Class 1


Premarket Reviews
ManufacturerDecision
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
  1.  K170882  ABL90 FLEX, ABL90 FLEX PLUS
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2018 5 5
2019 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
False Reading From Device Non-Compliance 2 2
Image Display Error/Artifact 1 1
Display Difficult to Read 1 1
No Display/Image 1 1
Improper or Incorrect Procedure or Method 1 1
Low Test Results 1 1
High Readings 1 1
Low Readings 1 1
Output Problem 1 1
Programming Issue 1 1
Function Indicator Light 1 1
Insufficient Information 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Jaundice 2 2
No Consequences Or Impact To Patient 1 1
Brain Injury 1 1
Neuropathy 1 1
Test Result 1 1
No Information 1 1
No Code Available 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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