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); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/10/2018 |
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 insulin pump had a flashing display.The customer¿s blood glucose level was 14 mmol/l at the time of the incident.The customer reported that display was flashing black and white and pump was very loud with peeping.Customer was using a pen.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Insulin pump passed the self-test, sleep current measurement, active current measurement, and displacement test.Insulin pump powered up properly after battery installation.No missing segments or partial display noted.The insulin pump was monitored for a day and no missing segments or display anomaly noted.
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Search Alerts/Recalls
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