MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712K |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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Information received by medtronic indicated that insulin pump had motor error alarm while trying to perform rewind or set reservoir in the insulin pump.No harm requiring medical intervention was reported.Customer tried to perform it again, but the same message appeared.The device will be returned for analysis.
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Manufacturer Narrative
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Device passed the self test, rewind test, prime or seating test, basic occlusion test, occlusion test, force sensor test and displacement test.No motor error alarm noted.The motor was tested outside of the device and passed.(b)(4).
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Search Alerts/Recalls
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