MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-554WWB |
Device Problems
Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/05/2018 |
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.The device has been returned, but not yet evaluated.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 alarmed compromised force sensor system.Customer¿s blood glucose level was 101 mg/dl.Customer also stated that the insulin was squirting out during manual prime.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Unable to confirm compromised forced sensor system alarm and unable to perform displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test due to detached end cap.
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Search Alerts/Recalls
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