Model Number MMT-754CML |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problem
Hyperglycemia (1905)
|
Event Date 07/12/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 paradigm real-time veo 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.
|
|
Event Description
|
It was reported that the customer received a button error alarm.Customer's blood glucose level at the time 6.0 mmol/l.Troubleshooting occurred.Advised to discontinue use of the insulin pump, and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
|
|
Manufacturer Narrative
|
The insulin pump was received with intermittent button response due to moisture damage on the keypad trace.No button error alarm.The insulin pump has minor scratched lcd window, cracked case near the display window corners and cracked reservoir tube lip.
|
|
Search Alerts/Recalls
|