| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00453-1 |
| Product Name/Description |
AQURE Data Management System
Software prior to version 1.8.2 may be affected. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
RADIOMETER has recently become aware of three potential issues with unit conversion in AQURE that may occur if the device is transmitting in a different unit than AQURE is displaying and/or transmitting to the HIS/LIS.
- Conversion of Ketone from mmol/l to mg/dl or vice versa: The parameter ketone is measured on either the Siemens Clinitek or the DocuReader. This is not applicable in Australia as none of these devices are connected to AQURE.
- Conversion of glucose and lactate from g/l to mmol/l or vice versa: In both cases a potential wrong conversion factor may be used, which may cause the reported result to be incorrect by a factor 10,000. This problem may be present in all versions of AQURE.
- Converting from mg/dl to mg/l and g/dl to g/l or vice versa: A potential wrong conversion factor may be used of 1/10. The correct factor is 10. Reported results may be incorrect by a factor 100. This problem is not parameter specific and may be present in all versions of AQURE. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are requested to not change the units on AQURE or iSTAT without consulting Radiometer Pacific. Radiometer will be carrying out testing to identify affected software and a software update will be installed to correct the issue. This action has been closed-out on 29/01/2016. |
| Contact Information |
1800 247 254 - ITS Business Manager |