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 insulin pump had a critical pump error. The blood glucose level at the time of the incident was 6 mmol/l. They stated no issues leading to the critical pump error. Troubleshooting was provided but nothing was resolved. The insulin pump will return for analysis.
Patient Sequence No: 1, Text Type: D, B5