MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LWWB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-554LWWB |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/02/2018 |
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 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 drive support cap was sticking out.Customer's blood glucose level was 166 mg/dl.Insulin pump will be returned for analysis.
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Manufacturer Narrative
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The insulin pump was received with detached end cap, cracked battery tube threads, broken off reservoir tube lip and missing end cap sticker.The drive support disk was inspected and no anomaly noted.
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Search Alerts/Recalls
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