MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712B; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712B |
Device Problems
Break (1069); Device Displays Incorrect Message (2591); Naturally Worn (2988)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/12/2018 |
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 customer had power error detected on insulin pump.The customer¿s blood glucose level was unknown.The customer also reported that the case and display window worn and damaged.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Pump passed the sleep current measurement, active current measurement, and displacement test.Pump error 25 due to a connector resistance issue.Pump received with scratched case, pillowing keypad overlay, cracked select button keypad overlay, fading serial number label, and minor scratched lcd window.
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