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T:SLIM G4 SYSTEM Adverse Event — Injury (MDR 3013756811-2020-41885)

T:SLIM G4 SYSTEM Adverse Event — Injury (MDR 3013756811-2020-41885) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: T:SLIM G4 SYSTEM; Generic name: INSULIN PUMP; Manufacturer: TANDEM DIABETES CARE.

DeviceT:SLIM G4 SYSTEM
Generic nameINSULIN PUMP
ManufacturerTANDEM DIABETES CARE
Report number3013756811-2020-41885
Event typeInjury
Product problemY
Date received2020-04-28
Report sourceCONSUMER
NarrativeDO NOT USE ANY OTHER INSULIN WITH YOUR PUMP OTHER THAN U-100 HUMALOG® OR NOVOLOG®. ONLY HUMALOG® AND NOVOLOG® HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE WITH THIS PUMP. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE VERY HIGH OR A VERY LOW BLOOD GLUCOSE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVAN
SourceopenFDA MAUDE (device adverse events)

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