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AUTOSOFT 90 Adverse Event — Injury (MDR 3003442380-2020-00257)

AUTOSOFT 90 Adverse Event — Injury (MDR 3003442380-2020-00257) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AUTOSOFT 90; Generic name: INSET II 60/9 GREY; Report number: 3003442380-2020-00257.

DeviceAUTOSOFT 90
Generic nameINSET II 60/9 GREY
Report number3003442380-2020-00257
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceDISTRIBUTOR
NarrativeUNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED A KINKED CANNULA ISSUE DUE TO WHICH HER BLOOD GLUCOSE LEVEL WAS RAISED TO 670 MG/DL AND SHE TRIED TO TREAT THIS ISSUE WITH A MULTIPLE DAILY INJECTION. THE INFUSION SET WAS USED FOR TWO DAYS. SUBSEQUENTLY, ON AN UNKNOWN DATE IN (B)(6) 2019, SHE WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC
SourceopenFDA MAUDE (device adverse events)

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