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
No Display/Image (1183)
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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 the insulin pump had a blank display.Customer stated the contacts on the battery cap were neither missing nor damaged.Display did not return after pump restart.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 received with blank display and constant tone due to moisture damage on the electronics assembly.Unable to perform all functional testing including the operating currents, self test and displacement test due to blank display.Device received with moisture damage motor, vibrator and battery tube assembly.
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