CLINICAL CHEMISTRY ANALYZER
This device is manufactured by ORTHO-CLINICAL DIAGNOSTICS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Non Reproducible Results | 1 | Device |
| 2024 | Low Test Results | 3 | Device |
| 2024 | High Test Results | 2 | Device |
| 2023 | Low Test Results | 1 | Device |
| 2023 | High Test Results | 3 | Device |
| 2022 | Low Test Results | 3 | Device |
| 2022 | False Positive Result | 1 | Device |
| 2019 | Protective Measures Problem | 1 | Device |
| 2019 | Patient Data Problem | 1 | Device |
| 2019 | Nonstandard Device | 1 | Device |
| 2019 | Low Test Results | 8 | Device |
| 2019 | Low Readings | 2 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 11 | Device |
| 2019 | High Test Results | 16 | Device |
| 2019 | High Readings | 5 | Device |
| 2018 | Patient Data Problem | 2 | Device |
| 2018 | Nonstandard Device | 10 | Device |
| 2018 | Low Test Results | 27 | Device |
| 2018 | Low Readings | 1 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 21 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2018 | Incorrect Measurement | 1 | Device |
| 2018 | Human Factors Issue | 1 | Device |
| 2018 | High Test Results | 51 | Device |
| 2018 | High Readings | 2 | Device |
| 2018 | False Negative Result | 1 | Device |
| 2018 | Device Markings/Labelling Problem | 2 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Computer Software Problem | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Patient Data Problem | 6 | Device |
| 2017 | Nonstandard Device | 1 | Device |
| 2017 | Low Test Results | 34 | Device |
| 2017 | Low Readings | 1 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 3 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 15 | Device |
| 2017 | High Test Results | 26 | Device |
| 2017 | High Readings | 1 | Device |
| 2017 | False Reading From Device Non-Compliance | 1 | Device |
| 2017 | Device Markings/Labelling Problem | 1 | Device |
| 2016 | Protective Measures Problem | 1 | Device |
| 2016 | Misassembly by Users | 2 | Device |
| 2016 | Malposition of Device | 1 | Device |
| 2016 | Low Test Results | 5 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2016 | Incorrect Measurement | 5 | Device |
| 2016 | High Test Results | 7 | Device |
| 2015 | Use of Device Problem | 2 | Device |
| 2015 | Suction Problem | 1 | Device |
| 2015 | Nonstandard Device | 8 | Device |
| 2015 | Low Test Results | 3 | Device |
| 2015 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2015 | Inaccurate Dispensing | 1 | Device |
| 2015 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2015 | Improper Flow or Infusion | 1 | Device |
| 2015 | High Test Results | 8 | Device |
| 2015 | Device Operates Differently Than Expected | 2 | Device |
| 2015 | Device Displays Incorrect Message | 1 | Device |
| 2015 | Contamination | 1 | Device |
| 2015 | Computer Software Problem | 5 | Device |
| 2015 | Aspiration Issue | 6 | Device |
| 2014 | Patient Data Problem | 4 | Device |
| 2014 | Nonstandard Device | 5 | Device |
| 2014 | Low Test Results | 10 | Device |
| 2014 | Loss of Data | 1 | Device |
| 2014 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 9 | Device |
| 2014 | Improper Flow or Infusion | 1 | Device |
| 2014 | Human Factors Issue | 1 | Device |
| 2014 | High Test Results | 11 | Device |
| 2014 | High Readings | 1 | Device |
| 2014 | Display or Visual Feedback Problem | 3 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Delivery System Failure | 1 | Device |
| 2014 | Contamination | 1 | Device |
| 2014 | Computer Software Problem | 3 | Device |
| 2014 | Aspiration Issue | 3 | Device |
| 2014 | Application Program Problem | 1 | Device |
| 2013 | Patient Data Problem | 1 | Device |
| 2013 | Low Test Results | 1 | Device |
| 2013 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2013 | High Readings | 1 | Device |
| 2013 | Display or Visual Feedback Problem | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 1 | Device |