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
Information indicated by medtronic that the insulin pump had a keypad anomaly. Customer stated that the middle button was unresponsive. Customer stated that numbers are not ramping on their own. Customer stated that the scroll bar was not moving with no input. Customer stated that alarm was not in progress at the time the button was unresponsive. Customer stated that the button was not unresponsive during an easy bolus attempt. No harm requiring medical intervention was reported. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5