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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood grouping reagent
Definition For red blood cell antigen typing
Product CodeQHR
Regulation Number 660.20
Device Class Unclassified

MDR Year MDR Reports MDR Events
2019 17 17
2020 84 84
2021 90 90
2022 64 64
2023 82 82
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 172 172
False Negative Result 70 70
Adverse Event Without Identified Device or Use Problem 51 51
Incorrect, Inadequate or Imprecise Result or Readings 32 32
Improper or Incorrect Procedure or Method 14 14
Output Problem 13 13
No Apparent Adverse Event 10 10
Defective Device 8 8
Defective Component 4 4
Incorrect Measurement 2 2
Off-Label Use 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 1 1
Short Fill 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 314 314
No Known Impact Or Consequence To Patient 47 47
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
Reaction 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Test Result 2 2
Hemolysis 1 1
Laceration(s) 1 1

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