Autosoft90™ 1000277Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244014428), received between Apr 9, 2019 and Mar 3, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, AN (B)(6)-YEAR-OLD FEMALE CHILD PATIENT EXPERIENCED STOMACHACHE, VOMITING, HIGH BLOOD GLUCOSE LEVEL AND HER KETONE LEVEL WAS 5.6 MMOL/L. THE PARENTS REMOVED THE INFUSION SET AND NOTICED THAT THE CANNULA WAS BENT. THEREFORE, THE PARENTS CALLED THE HEALTH CARE PROFESSIONAL AND TOOK THE PATIENT TO THE HOSPITAL ON THE SAME DAY OF THIS EVENT ((B)(6) 2021). AT THE HOSPITAL, THE PUMP WAS DISCONNECTED. MOREOVER, HER HIGHEST BLOOD GLUCOSE LEVEL WAS 270 MG/DL AND THE INFUSION SET HAD BEEN USED FOR A DAY ((B)(6) 2021). DURING HOSPITALIZATION, SHE RECEIVED INSULIN INJECTION AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. ON (B)(6) 2021, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. AFTER RETURNING HOME, THE PATIENT RESUMED USE OF THE PUMP. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 11403197 ↗
• MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE CONNECTOR NEEDLE PORTION OF THE SITE DISCONNECTED FROM THE PATIENT LINE TUBING DUE TO WHICH BLOOD GLUCOSE LEVEL WAS ELEVATED (IN 300S MG/DL) AND WAS THEN RESOLVED AFTER THE PATIENT APPLIED A NEW INFUSION SET. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494281 ↗