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 Problems
Unable to Obtain Readings (1516); Material Deformation (2976); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/09/2018 |
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 insulin pump had cosmetic damage.Blood glucose was 119 mg/dl.Customer reported scratched screen and it was not readable.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device received with minor scratched lcd window, cracked battery tube threads, missing retainer, missing reservoir tube o-ring and broken reservoir tube lip.Unable to perform displacement test or lock reservoir in place due to missing retainer.
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Search Alerts/Recalls
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