Autosoft30™ 007288Recalls & reported problems
Unomedical A/S · t:30 infusion set. Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 05705244004634), received between Apr 22, 2019 and Apr 22, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Loss of or Failure to Bond1
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 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HER INFUSION SET DISLODGED FROM HER BODY AS THE ADHESIVE WAS NOT STICKING. SHE WAS NOT RECEIVING INSULIN DUE TO WHICH SHE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL. SHE TOOK 28 UNITS OF INSULIN THROUGH THE PUMP IN A 12 HOUR PERIOD WITHOUT EATING. SHE WENT TO THE EMERGENCY ROOM FOR 3 HOURS AND RECEIVED FLUIDS AND INSULIN AS CORRECTIVE TREATMENT. HER BLOOD GLUCOSE LEVEL WAS 712 MG/DL WHEN SHE ARRIVED AT THE EMERGENCY ROOM. THE HEALTH CARE PROFESSIONAL HAD ASSESSED HER KETONE LEVEL AS DANGEROUS/LIFE THREATENING. SUBSEQUENTLY, SHE WAS HOSPITALIZED, AND HER BLOOD GLUCOSE LEVEL WAS 148 MG/DL WHEN SHE LEFT THE EMERGENCY ROOM. SHE WAS CLEARED FROM DIABETIC KETOACIDOSIS AND HER BLOOD GLUCOSE LEVEL WAS REDUCED TO TARGET RANGE. DURING HOSPITALIZATION, HER BASAL RATE WAS ADJUSTED, AND SHE RECEIVED FLUIDS AND INSULIN AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE WAS HOSPITALIZED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8534976 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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