MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
|
Back to Search Results |
|
Model Number MMT-1711K |
Device Problem
Date/Time-Related Software Problem (2582)
|
Patient Problem
Pregnancy (3193)
|
Event Date 01/21/2020 |
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.(b)(4).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
|
Information received by medtronic indicated that the insulin pump was losing or gaining time more than 9 minutes within 30 days.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
|
|
Manufacturer Narrative
|
Device passed displacement test, rewind, prime or seating, basic occlusion, force sensor test, occlusion test and self test.Device monitored for 3 days.No time and clock anomaly noted during testing.(b)(4).
|
|
Search Alerts/Recalls
|
|
|