MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
|
Back to Search Results |
|
Model Number MMT-1712K |
Device Problems
Break (1069); Device Displays Incorrect Message (2591); Naturally Worn (2988)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/03/2018 |
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 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.
|
|
Event Description
|
It was reported that their insulin pump had received a power error detected alarm and was damaged.The customer¿s blood glucose level was unknown.The customer states that the power error occurred every 4 hours and case and display window worn and damaged.The insulin pump will be returned for analysis.
|
|
Manufacturer Narrative
|
Device passed the sleep current measurement, active current measurement, and displacement test.Device trace download analysis confirmed the device alarmed power error 25.The power management tool confirmed power error 25 alarm was triggered when the backup battery unloaded voltage was less than 3.7voltz for 240 consecutive minutes due to non-sleep anomaly software error.Device received with cracked select button keypad overlay, stained keypad, and a minor scratched lcd window.
|
|
Search Alerts/Recalls
|
|
|