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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Product CodeMTF
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
14 6 5 10 4 5

MDR Year MDR Reports MDR Events
2020 14 14
2021 46 46
2022 45 45
2023 30 30
2024 35 35
2025 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 118 118
Low Test Results 61 61
Non Reproducible Results 22 22
Incorrect Measurement 20 20
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Output Problem 2 2
Insufficient Information 2 2
Signal Artifact/Noise 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Low Readings 1 1
Failure to Calibrate 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 188 188
No Consequences Or Impact To Patient 10 10
Osteopenia/ Osteoporosis 9 9
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 4 4
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Nov-14-2024
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