MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1711K |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 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 the drive count error boundaries exceeded movement alarm occurred on the insulin pump.Customer stated the issue recurred multiple times and the issue remained unresolved.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device passed the displacement test, self test, rewind test, prime/seating test, basic occlusion test, force sensor test and occlusion test.No unexpected insulin flow blocked alarm or no delivery alarm noted during testing.No unexpected pump error 42 noted.(b)(4).
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