Autosoft90™ 005913Recalls & reported problems
Unomedical A/S · t:90 infusion set. 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 05705244004511), received between Apr 30, 2019 and Apr 30, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Infusion or Flow 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
- Infusion or Flow 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.
InjuryApr 30, 2019Infusion or Flow Problem; Infusion or Flow Problem
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT INSULIN WAS NOT COMING FROM THE TUBING LINE AND THE PATIENT WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. PATIENT'S BLOOD GLUCOSE LEVEL WAS 626 MG/DL WHEN SHE WAS ADMITTED IN THE HOSPITAL. PRIOR TO HOSPITALIZATION, THE PATIENT TRIED DELIVERING INJECTIONS, BOLUSES, AND INCREASING THE TEMPERATURE RATE ON THE PUMP BUT STATED BLOOD GLUCOSE LEVEL DID NOT COME DOWN. DURING HOSPITALIZATION, PATIENT RECEIVED INSULIN AND FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION HAD BEEN IN USE FOR LESS THAN 2 DAYS. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8564260 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.