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PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL Adverse Event — Malfunction (MDR 2032227-2020-111169)

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL Adverse Event — Malfunction (MDR 2032227-2020-111169) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL; Generic name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVAS

DevicePARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
Generic namePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SE
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Report number2032227-2020-111169
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER
Narrative(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. 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.
SourceopenFDA MAUDE (device adverse events)

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