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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, vitamin d
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 38 38
2020 10 10
2021 15 15
2022 13 13
2023 22 22
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 75 75
Non Reproducible Results 50 50
Low Test Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Incorrect Measurement 5 5
High Readings 3 3
Low Readings 3 3
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Degraded 1 1
Chemical Problem 1 1
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Consequences Or Impact To Patient 49 49
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
No Patient Involvement 1 1

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