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
Mechanical Problem (1384)
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Patient Problem
Shock, Insulin (2264)
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Event Date 09/19/2019 |
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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It was reported that the insulin pump alarmed broken force sensor was detected during seating or regular delivery.The customer¿s blood glucose level was 6.8 mmol/l at the time of the incident.Customer stated troubleshooting was performed.Customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan per health care professional instructions.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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The p-cap does not lock properly due to missing retainer.Device received with critical pump error and pump error 35 confirmed in history file due to moisture damage to force sensor.Device received with corroded electronic assemblies, corroded battery tube and corroded motor home switch.
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Search Alerts/Recalls
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