Autosoft90™ 1000280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244014510), received between Jan 25, 2019 and Apr 24, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT ROUGHLY 5-6 MONTHS BEFORE THIS REPORT, THE PATIENT HAD INFUSION SETS THAT WERE BENDING UNDER HIS SKIN CAUSING HIS BLOOD SUGAR LEVEL TO RISE TO ALMOST 1000 MG/DL. THE PATIENT CHANGED OUT THE SITE AND DELIVERED A BOLUS. THE PATIENT ALSO EXPERIENCED DIABETIC KETOACIDOSIS DUE TO WHICH HE WAS HOSPITALIZED. HE WAS PUT ON AN INSULIN DRIP AND AN INSULIN DRIP WITH DEXTROSE, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND HE WAS RELEASED FROM THE HOSPITAL AFTER THREE DAYS. 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 8543478 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE DUE TO WHICH HE EXPERIENCED DIABETIC KETOACIDOSIS. PATIENT'S BLOOD GLUCOSE LEVEL HAD RISEN TO 500S MG/DL AT THE TIME OF THE EVENT. THE PATIENT CHANGED OUT THE SITE AND TRIED TO DELIVER A BOLUS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE HE WAS PUT ON AN INSULIN DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS AND THE PATIENT STAYED IN THE HOSPITAL FOR TWO DAYS. 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 8543457 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE DUE TO WHICH HE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL. THE PATIENT TRIED TO CHANGE SUPPLIES AND DELIVERED CORRECTION BOLUS. THE PATIENT WENT TO THE EMERGENCY ROOM AND UPON ARRIVAL, BLOOD GLUCOSE LEVEL WAS REPORTED TO BE BETWEEN 650 MG/DL AND 670 MG/DL. HE RECEIVED THREE BAGS OF INTRAVENOUS FLUIDS WITHIN 30 MINUTES AND RECEIVED AN INSULIN DRIP. THE PATIENT STAYED THERE FOR 12 HOURS BUT SINCE HE STILL DID NOT FEEL WELL, HE WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. HE RECEIVED INSULIN SHOTS AND INSULIN VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY TWO DAYS AND THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS. 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 8534856 ↗
• InjuryJan 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED CANNULA WAS BENT DUE TO WHICH PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF MORE THAN 500 MG/DL AND SELF-TREATED WITH PUMP BOLUSES. THE INFUSION SET WAS IN USE FOR LESS THAN THREE DAYS. THE PATIENT HAD KETONE LEVEL AND THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS/LIFE THREATENING. THE PATIENT WAS NOT FEELING WELL AND ADMITTED TO EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL AND DIABETES KETOACIDOSIS, WHILE IN EMERGENCY ROOM THE PATIENT RECEIVED INTRAVENOUS INSULIN AND FLUIDS AS CORRECTIVE TREATMENT. THE PATIENT FELT SICK AND LETHARGIC AND WAS ADMITTED TO THE HOSPITAL/ICU A THE PATIENT RECEIVED INTRAVENOUS FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR MORE THAN 3 DAYS. 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 8276831 ↗