Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its DxH 500 Hematology Analyser [Reference: B40601; Software versions 1.0.2].
As a result of internal investigations, the manufacturer has become aware that when the instrument temperature (<18°C to >36.5°C) is exceeded, the DxH 500 allows sample processing and result reporting despite the Instructions for Use stating that "The run sample is inaccessible". Results generated in this scenario may be erroneous. Additionally:
- The message on the results screen/printout reads "Instrument Temperature" instead of "Instrument Temperature Out of Range".
- The results are transmitted to the Laboratory Information System (LIS) without the accompanying "Instrument Temperature Out of Range" message. Using the auto-transmit option could lead to the release of erroneous results to the LIS.
If the instrument is operating out of the temperature range and the warnings on the screen are ignored and the results are used, then:
- These CBC, WBC-DIFF or CBC/WBC-DIFF results may be erroneous.
- If these erroneous results are released to the physician, this could result in inappropriate patient management.
The manufacturer advises affected users to take the following actions:-
- When the message "Instrument Temperature Out of Range" or "Instrument Temperature" is displayed on the system or printouts, DO NOT report the patient results.
- Ensure the laboratory ambient temperature is within specifications (18°C -32°C) when processing samples.
- Disable the auto-transmit option if there is a potential for the operational temperature to be exceeded.
- Consult with the Medical Director to determine if a retrospective review of results is warranted.
This issue will be corrected in a future software release.
According to the local supplier, the affected products are distributed in Hong Kong
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 May 2017