MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-754LWWH |
Device Problems
Premature Discharge of Battery (1057); Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/04/2019 |
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 paradigm real-time veo 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 multiple insulin pump error alarm.The customer¿s blood glucose level was unknown at the time of the incident.Customer stated they were able to clear the alarm and they were able to rewind insulin pump.Customer stated alarm immediately followed a battery change.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Insulin pump passed displacement test, self test, a21 error test, off no power test and all operating currents tested within the specific range.No unexpected low battery alarm were noted.
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Search Alerts/Recalls
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