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 Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912)
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Event Date 05/07/2018 |
Event Type
Injury
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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 as well as low blood glucose of 275 mg/dl.Customer¿s blood glucose was 498mg/dl, 490mg/dl.The customer did not experience any symptoms such as a result of high blood glucose.For low blood glucose the customer treated with food.Troubleshooting was done for high and low blood glucose.The drive support cap appears flush.The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose.Based on customer report customer did not allege insulin pump was over delivering.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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No unexpected no delivery alarm noted during testing.Device passed rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No unexpected prime or fill anomaly noted during testing.
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Search Alerts/Recalls
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