MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-554WWP |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/31/2017 |
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 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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The customer reported via phone call that the reservoir does not stay locked in the pump.They had lower blood glucose the morning of the call but later that day, it rose to 7.0 mmol/l.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Findings: pump received with cracked case at the display window corner, major broken reservoir tube lip, minor scratched lcd window, missing reservoir tube o-ring, stained end cap sticker and cracked battery tube threads.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip noted.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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Search Alerts/Recalls
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