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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ion specific, potassium
Product CodeCEM
Regulation Number 862.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAMOND DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 27 27
2021 18 18
2022 16 16
2023 32 32
2024 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 44 44
High Test Results 31 31
Low Readings 15 15
Mechanical Problem 14 14
Insufficient Information 13 13
Use of Device Problem 12 12
Non Reproducible Results 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Incorrect, Inadequate or Imprecise Result or Readings 6 6
High Readings 6 6
Incorrect Measurement 5 5
Output Problem 3 3
Erratic Results 3 3
Smoking 3 3
Computer Software Problem 3 3
Unable to Obtain Readings 2 2
Calibration Problem 2 2
Installation-Related Problem 2 2
No Apparent Adverse Event 2 2
Improper Chemical Reaction 2 2
Improper or Incorrect Procedure or Method 2 2
Mechanical Jam 2 2
Chemical Problem 1 1
Unexpected Shutdown 1 1
Device Contamination with Body Fluid 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembled During Installation 1 1
Material Fragmentation 1 1
Improper Flow or Infusion 1 1
Thermal Decomposition of Device 1 1
Sharp Edges 1 1
Electrical Shorting 1 1
Component Misassembled 1 1
Failure to Calibrate 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 19 19
Death 3 3
Insufficient Information 3 3
Laceration(s) 3 3
Test Result 2 2
Injury 2 2
Unspecified Infection 1 1
Joint Dislocation 1 1
Electric Shock 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Cardiac Arrest 1 1
Muscle/Tendon Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-03-2020
2 Inpeco S.A. II Dec-15-2023
3 Inpeco S.A. II May-04-2023
4 Inpeco S.A. II Oct-12-2021
5 Inpeco S.A. II Nov-06-2020
6 Inpeco S.A. II Sep-16-2020
7 Inpeco S.A. II Jun-01-2020
8 Inpeco S.A. II May-26-2020
9 Inpeco S.A. II May-14-2020
10 Ortho-Clinical Diagnostics II Nov-01-2019
11 Radiometer America Inc II Aug-22-2019
12 Radiometer Medical ApS II Jun-15-2021
13 Radiometer Medical ApS II Apr-22-2020
14 Randox Laboratories Ltd. II Oct-31-2023
15 Randox Laboratories Ltd. II Jul-26-2021
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