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
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2017 |
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 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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The customer reported for display flashing.The customer¿s blood glucose level was 140 mg/dl at the time of the incident.Customer reported display flashing or solid white after insulin pump was bumped and swimming.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 moisture damage on the electronic assembly.Also, device received with moisture damage on the battery tube, motor, vibrator and keypad flex tail noted.No moisture damage on the keypad traces or keypad dome switches noted.Unable to verify led anomaly, flashing or solid white display due to blank display.
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