Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Kaluza C Software [Version: 1.0, 1.1.1, 1.1.2, Part Number: C10574, C10575, C10576, C10577, C10578, C10579, C10580, C10581, C21166].

The manufacturer has discovered software anomalies in Kaluza C that may lead to the generation of erroneous results which could lead to two issues.

For issue one, affecting Version: 1.0, 1.1.1, 1.1.2, transmission of erroneous results to the Laboratory Information System (LIS) may occur any time a gate has been setup for LIS transmission and one or more gates in the data plot has been deleted. The following corrective actions are advised to affected users:

• If using a LIS,
  • Review the values in the LIS Preview window for each patient and verify that they correspond to the Kaluza C data plot statistics.
  • If erroneous results are seen, remove the incorrect statistic from the LIS Preview window.
  • Update the LIS export to include the desired gate statistic following the Kaluza C IFU instructions (Exporting Data to the LIS). Save changes.
  • Verify all LIS Preview window results and transmit to the LIS.
  • Consult with Medical Director to determine if a retrospective review of results is warranted.
  • Report any erroneous results to the manufacturer.

For issue two, affecting Version: 1.1.1, 1.1.2, the autofluorescence values Kaluza C loads from the listmode (LMD) file do not match the values set in the Advanced Compensation Module of Navios or Navios EX. For this issue, the following corrective actions are advised:

• If users are using Kaluza C with the Advanced Compensation Module of Navios or Navios EX:
  • Review the statistical results derived from measurements of fluorescence intensity.
  • If erroneous results are observed, manually adjust autofluorescence values, re-analyse the data using the adjusted autofluorescence values and verify that the correct values are generated.
  • Consult with Medical Director to determine if a retrospective review of results is warranted.
  • Report any erroneous results to the manufacturer.

These issues could cause a delay in initiating antiretroviral therapy and anti-opportunistic infection preventive treatment, with attendant complications (e.g. opportunistic infections) and disease progression for CD4+ enumeration panel. The manufacturer will provide a software update to resolve these issues.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary action.

Posted on 5 July 2021