Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time. The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the customer's insulin pump alarmed with a critical pump error. The customer's blood glucose level was 6. 8 mmol/l at the time of the incident. No other pump errors were displayed before the open book image was displayed on the screen. Customer was advised to discontinue use of the pump and recommend customer refer to back up plan. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5