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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

MDR Year MDR Reports MDR Events
2018 13 13
2019 25 25
2020 27 27
2021 18 18
2022 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 22 22
Low Test Results 12 12
Low Readings 12 12
Mechanical Problem 12 12
Insufficient Information 10 10
High Readings 7 7
Use of Device Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Erratic Results 3 3
Smoking 3 3
Non Reproducible Results 2 2
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Overheating of Device 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Material Fragmentation 1 1
Calibration Problem 1 1
Electrical Shorting 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 27 27
No Consequences Or Impact To Patient 25 25
Death 3 3
Laceration(s) 2 2
Injury 2 2
Test Result 2 2
Unspecified Infection 1 1
Insufficient Information 1 1
Electric Shock 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-03-2020
2 Inpeco S.A. II Oct-12-2021
3 Inpeco S.A. II Nov-06-2020
4 Inpeco S.A. II Sep-16-2020
5 Inpeco S.A. II Jun-01-2020
6 Inpeco S.A. II May-26-2020
7 Inpeco S.A. II May-14-2020
8 Ortho-Clinical Diagnostics II Nov-01-2019
9 Radiometer America Inc II Aug-22-2019
10 Radiometer Medical ApS II Jun-15-2021
11 Radiometer Medical ApS II Apr-22-2020
12 Randox Laboratories Ltd. II Jul-26-2021
13 Roche Diagnostics Corporation II May-03-2018
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