inset™ 005760Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244016866), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Handling Problem1
Patient problems
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2019Device Handling Problem; Device Handling Problem
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES THE PATIENT HAD DEPLOYMENT ISSUES WITH 3 INFUSION SETS, SO DID NOT RECEIVED INSULIN THAT LED TO HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. THE PATIENT HAD NOT ENTERED THE CANNULA PROPERLY, SO WAS ALSO EXPERIENCING LEAKING AROUND THE SITE. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED, TOOK MULTIPLE DAILY INJECTION THEREAFTER AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. REPORTEDLY THE KETONES WERE HIGH, AND THE PATIENT RECEIVED INSULIN AND INTRAVENOUS FLUIDS AS A CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8361038 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.