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
Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/14/2017 |
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 paradigm real-time 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 via phone call that the insulin pump was alarming and had a flashing display.The device had been dropped.They were calling back with a blank display after an insulin pump rest.They were calling back after receiving a new battery cap.The customer¿s blood glucose level was unknown.They were advised that the device would be replaced and agreed to return the product for analysis.
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Manufacturer Narrative
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After battery installation the device gave an unexpected flashing medtronic logo on display, problem was isolated to electrical board.No blank display anomaly noted.Unable to perform the self test, sleep current measurement, active current measurement, and the displacement test or verify missing segments and partial display due to display anomaly.The device was received with minor scratched display window, case and keypad overlay.
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Search Alerts/Recalls
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