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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 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 82 82
Non Reproducible Results 63 63
Low Test Results 18 18
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 5 5
Low Readings 5 5
High Readings 4 4
Material Integrity Problem 3 3
Chemical Problem 1 1
Insufficient Information 1 1
Device Damaged Prior to Use 1 1
Degraded 1 1
Unable to Obtain Readings 1 1
Appropriate Term/Code Not Available 1 1
Failure to Calibrate 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
No Consequences Or Impact To Patient 49 49
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 1 1
Insufficient Information 1 1

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