MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712K |
Device Problem
No Display/Image (1183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/24/2019 |
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 had blank display.Customer¿s blood glucose level was 150 mg/dl.Customer reported that the insulin pump had white display during normal use and there was no damage, no dropped or bumped.Customer removed battery after 30 minutes then insert new one but insulin pump not started.Customer stated that battery compartment was corrected.The device will be returned for analysis.
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Manufacturer Narrative
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Device received with blank display due to corroded electronics assembly.Motor and force sensor was also corroded.Unable to perform displacement test, sleep current measurement test, active current measurement test and self test due to blank display.
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