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
Unable to Obtain Readings (1516)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2018 |
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 the insulin pump display was not readable.The customer¿s blood glucose level was 117 mg/dl at the time of the incident.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device received with blank display due to shifted battery tube assembly.Unable to perform displacement test, sleep current measurement, active current measurement and selftest due to blank display.Device received with cracked battery tube area.
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Search Alerts/Recalls
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