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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, oral direct thrombin inhibitor
Definition An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
Product CodeQBG
Device Class Not Classified

MDR Year MDR Reports MDR Events
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 2 2
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 1 1
Diaphoresis 1 1
Confusion/ Disorientation 1 1
Insufficient Information 1 1

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