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)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/17/2017 |
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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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Customer reported for flashing white display.Customer's blood glucose was 6.5 mmol/l.Customer reported that insulin pump stopped working suddenly and started alarming.Screen is flashing white and black and insulin pump is alarming.Customer reported that they removed battery but this did not help.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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After battery installation unit gave an unexpected flashing white / blank display followed by an unexpected intermittent beep alarm due to cracked lcd controller.Unable to perform functional testing including self test, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test due to display anomaly.
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Search Alerts/Recalls
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