MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-523NAP |
Device Problems
Device Difficult to Program or Calibrate (1496); Priming Problem (4040)
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Patient Problem
Reaction, Injection Site (2442)
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Event Date 10/21/2020 |
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.No conclusion can be drawn at this time.We therefore, consider this report complete to the best of our knowledge.
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Event Description
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Information received by medtronic indicated that the insulin pump had buttons slower to respond, forced to restart when priming and insulin gushes out when priming.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
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Search Alerts/Recalls
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