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
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2017 |
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.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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The customer reported via phone call that the insulin pump had a flashing display.The patient¿s blood glucose level was unknown at the time of the incident.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device is not expected to be returned for analysis.
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Manufacturer Narrative
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The device had blank flashing white lcd due to cracked lcd controller.Unable to verify missing segments due to blank flashing white lcd.Unable to perform the self test, sleep current measurement, active current measurement and displacement test due to blank flashing white lcd.
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