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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
Patient Data Problem 8 8
Computer Software Problem 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Incorrect Or Inadequate Test Results 7 7
Device Operates Differently Than Expected 7 7
High Test Results 5 5
Maintenance Does Not Comply To Manufacturers Recommendations 4 4
Data Problem 3 3
Shelf Life Exceeded 3 3
Low Test Results 3 3
Use of Incorrect Control/Treatment Settings 2 2
Incorrect Measurement 2 2
No Display/Image 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Displays Incorrect Message 2 2
Display Difficult to Read 1 1
Product Quality Problem 1 1
Low Readings 1 1
Improper Device Output 1 1
False Positive Result 1 1
Device Reprocessing Problem 1 1
Device Handling Problem 1 1
Device Issue 1 1
Application Program Problem 1 1
Insufficient Information 1 1
Mechanical Problem 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1
Device Markings/Labelling 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
Anemia 1 1
Abnormal Blood Gases 1 1
Pulmonary Dysfunction 1 1
No Code Available 1 1
Cardiac Arrest 1 1
Loss of consciousness 1 1
Missing Value Reason 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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