AUTOSOFT 90 Adverse Event — Injury (MDR 3003442380-2020-00254)
AUTOSOFT 90 Adverse Event — Injury (MDR 3003442380-2020-00254) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AUTOSOFT 90; Generic name: INSET II 2-PACK 60/6 GREY TCAP; Report number: 3003442380-2020-00254.
| Device | AUTOSOFT 90 |
|---|---|
| Generic name | INSET II 2-PACK 60/6 GREY TCAP |
| Report number | 3003442380-2020-00254 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER FACED A KINKED CANNULA AND SHE WAS NOT ABSORBING INSULIN DUE TO WHICH SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. HER HIGHEST BLOOD GLUCOSE LEVEL WAS ABOUT 900 MG/DL. THEREFORE, THEY CHANGED THE INFUSION SET AND ADMINISTERED A BOLUS, BUT IN THE MONTH OF (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL D |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →