An issue with the translation of the operator id or patient id was alleged with the urisys 1100 analyzer.The issue occurred intermittently at several different sites across southern sweden and with at least 40 different urisys 1100 instruments.Refer to the attachment to the medwatch for all involved serial numbers.The analyzers use a barcode scanner connected to a moxa box and are sending the data to a third party middleware aqure data management system.After the user scanned an operator id or a patient id, in the aqure system it appeared one of the digits would be changed.The issue was only detectable in the middleware when the data did not match what was expected.For example, the correct operator id was "(b)(6)", but the aqure system showed the operator id as "(b)(6)".In this example, the aqure system would create a new user as a blank space followed by the five digits, thus losing traceability of who actually operated the device.There was no report of any incorrect result being reported to a person making a treatment decision due to an incorrect patient id.There was no report of any adverse event.An issue with the barcode scanner was ruled out because if the scanner read the wrong barcode, the analyzer would not let them log in.It was suspected there was an issue with the analyzer or the moxa box conversion of the serial data to the tcp/ip.As the issue was intermittent, the settings of the moxa box were believed to be correct.
|
A specific root cause could not be determined.Most probably, there were electromagnetic interferences which caused the issue.This interference could have an impact on instrument, communication between instrument and moxa box, or between moxa box and host system.Product labeling states the instrument must not be placed closely to electromagnetic devices.
|