MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712K |
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 05/04/2018 |
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 paradigm real-time 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 insulin pump had a flashing display.The customer¿s blood glucose level was unknown.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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After battery installation the device gave an unexpected flashing white and black display followed by an unexpected intermittent beep alarm due to vertical cracked lcd controller.Unable to perform the self test, sleep current measurement, active current measurement, displacement test or verify missing segments and partial display due to display anomaly.
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