MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711B; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1711B |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.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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It was reported via phone call on that the insulin pump had a blank display.The customer¿s blood glucose level was 7.2 mmol/l at the time of the incident.The customer noted the screen was continuously flashing black and white, and was not functional.Troubleshooting did not occur.The customer was advised a replacement insulin pump will be sent out and to use a backup plan per healthcare professional's recommendation.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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Device received with a constant blank flashing white light on the display followed by an unexpected intermittent beep alarm due to vertically cracked lcd controller.Unable to perform the self test, displacement test or verify missing segments and partial display due to blank display.
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