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PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB Adverse Event — Malfunction (MDR 2032227-2020-110553)

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB Adverse Event — Malfunction (MDR 2032227-2020-110553) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB; Generic name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVAS

DevicePARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
Generic namePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SE
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Report number2032227-2020-110553
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCONSUMER
NarrativeDEVICE RECEIVED UNABLE TO PERFORM ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST OR VERIFY A33 ALARM DUE TO COMPLETELY BROKEN RESERVOIR TUBE LIP. DEVICE RECEIVED WITH LOOSE DRIVE SUPPORT DISK. DEVICE RECEIVED WITH BROKEN RESERVOIR TUBE LIP. A TEST RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO COMPLETE BROKE
SourceopenFDA MAUDE (device adverse events)

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