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 Problems
Device Displays Incorrect Message (2591); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/14/2017 |
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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The customer reported via phone call that their insulin pump alarmed drive count/time values or changes incorrect for moving or coasting, too slow or too fast.The patient¿s blood glucose level was unknown at the time of the incident.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The alleged device is expected to be returned for analysis.
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Manufacturer Narrative
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Device passed rewind test, prime test, basic occlusion test, occlusion test, force sensor test and displacement test.No drive count or time values or changes incorrect for moving or coasting error noted during testing.
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Search Alerts/Recalls
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