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 Problems
Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591); Battery Problem (2885); Power Problem (3010)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/29/2018 |
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 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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It was reported that the customer insulin pump had a power error detected.The customer¿s blood glucose level was 12.2 mmol/l.Customer stated that they had constant battery issues and also reported power error detected alarm.The customer was able to successfully clear the alarm.Customer was able to complete pump rewind.The troubleshooting was performed and was advised to remove the aa battery from the pump and monitor the notification light and the notification light stopped flashing immediately.The customer was advised that the insulin pump will need to be replaced and was advised to refer to back up plan per health care professional instructions.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device received with operational currents within spec and passed self test and displacement test.Power error due to connector resistance electrical board.No low battery alert, power loss alarm, replace battery alert, replace battery now alarm noted during testing.
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