Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its DxH 500 (Part number: B40601, software versions 1.0.0 and 1.0.1).
The manufacturer is notifying users regarding an error in the Result Abnormal Flags field transmitted from the DxH 500 to the Laboratory Information System (LIS). Test values are not affected. According to the manufacturer, the logic for the "A" code used in the Result Abnormal Flags field is reversed for all test parameters. This letter does not apply if the user's laboratory is not transmitting results to an LIS or if the LIS driver does not use the Result Abnormal Flags field.
The test results and flags generated by the instrument are correct and are not affected by this issue. The definitive messages, system messages, parameter flags and codes, reference intervals and action limit flags are displayed, printed and transmitted to the LIS correctly. However, there is an additional flag, Result Abnormal Flag, which is only transmitted to the LIS that is incorrect. If the LIS is using the Result Abnormal Flags field, the LIS may incorrectly interpret results. Specifically, correct normal values may be erroneously flagged as abnormal and correct yet abnormal results may be missing the abnormal flag. 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 9 March 2016