MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-723NAS |
Device Problems
High Test Results (2457); Noise, Audible (3273)
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Patient Problem
Hyperglycemia (1905)
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Event Date 01/01/2018 |
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.
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Event Description
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The customer reported via phone call that they experienced high blood glucose level and they contact to their healthcare professional.The customer¿s blood glucose level was 250 to 350 mg/dl.Customer stated that the insulin pump had weird clicking noise from the motor mainly when he boluses.The drive support cap appears normal.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Insulin pump passed the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No device deficiency anomaly noted during test.
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Search Alerts/Recalls
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