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
Break (1069); Positioning Problem (3009)
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Patient Problem
Hyperglycemia (1905)
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Event Date 05/11/2017 |
Event Type
Injury
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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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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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Customer´s mother reported via phone call, the retainer ring on the insulin pump was damaged.Customer's blood glucose has been increasing as reservoir was not sitting properly in the reservoir compartment.Customer does not feel well.The device is being replaced.The device is returning for analysis.
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Manufacturer Narrative
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Unit received with missing retainer ring and reservoir tube lip o-ring.Unit received with cracked reservoir tube lip.Unable to perform displacement test due to physical damage.Unit received with cracked keypad overlay at select button.Unit received with minor scratched display window, case and keypad overlay.
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Search Alerts/Recalls
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