T:SLIM X2 INSULIN PUMP Adverse Event — Injury (MDR 3013756811-2020-42354)
T:SLIM X2 INSULIN PUMP Adverse Event — Injury (MDR 3013756811-2020-42354) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: T:SLIM X2 INSULIN PUMP; Generic name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SE; Manufacturer: TANDEM DIABETES CARE.
| Device | T:SLIM X2 INSULIN PUMP |
|---|---|
| Generic name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SE |
| Manufacturer | TANDEM DIABETES CARE |
| Report number | 3013756811-2020-42354 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE USER GUIDE STATES ¿HUMALOG® OR NOVOLOG® . ONLY HUMALOG® AND NOVOLOG® HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. 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 RELEVANT INFORMATION BECOME AVAILABLE, A SUP |
| Source | openFDA MAUDE (device adverse events) |
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