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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, hemoglobin, automated
Product CodeGKR
Regulation Number 864.5620
Device Class 2


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIASPECT MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
EKF-DIAGNOSTIC GMBH
  SUBSTANTIALLY EQUIVALENT 4
HEMOCUE AB
  SUBSTANTIALLY EQUIVALENT 2
IMMUNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEC DYNAMICS CORP
  SUBSTANTIALLY EQUIVALENT 1
STANBIO LABORATORY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 31 31
2015 19 19
2016 9 9
2019 9 9
2020 1 1
2021 1 1
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 10 10
Solder Joint Fracture 8 8
Computer Software Problem 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Patient Data Problem 8 8
Device Operates Differently Than Expected 7 7
Incorrect Or Inadequate Test Results 7 7
High Test Results 5 5
Maintenance Does Not Comply To Manufacturers Recommendations 4 4
Data Problem 3 3
Low Test Results 3 3
Shelf Life Exceeded 3 3
Incorrect Measurement 2 2
Use of Incorrect Control/Treatment Settings 2 2
No Display/Image 2 2
Device Displays Incorrect Message 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Insufficient Information 1 1
Device Reprocessing Problem 1 1
Improper Device Output 1 1
Device Handling Problem 1 1
Application Program Problem 1 1
Device Markings/Labelling Problem 1 1
Device Issue 1 1
Low Readings 1 1
Display or Visual Feedback Problem 1 1
False Positive Result 1 1
Display Difficult to Read 1 1
Mechanical Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 43 43
No Consequences Or Impact To Patient 24 24
Loss of consciousness 1 1
No Code Available 1 1
Missing Value Reason 1 1
Abnormal Blood Gases 1 1
Anemia 1 1
Cardiac Arrest 1 1
Pulmonary Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hemo Cue, Inc. II Mar-30-2011
2 HemoCue AB II Oct-29-2013
3 ITC-Nexus Dx, Inc. II Mar-31-2011
4 Siemens Healthcare Diagnostics, Inc. II Aug-24-2018
5 Stanbio Laboratory, LP II Aug-24-2018
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