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
Device Alarm System (1012); Failure of Device to Self-Test (2937); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2017 |
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.The device has been returned, but not yet evaluated.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 beep/vibrate anomaly.The customer¿s blood glucose level was 5 mmol/l at the time of the incident.It was stated no alert or alarm received.The customer completed troubleshooting.Displacement test was performed and passed.However, the device failed the self test.The insulin pump was returned for analysis.
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Manufacturer Narrative
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All operating currents are within specification.Device passed displacement test and self test.Multiple boluses were program and delivered.No unexpected noise noted during testing.Device functioning properly.(b)(4).
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Search Alerts/Recalls
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