Autosoft90™ 1000276Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244014398), received between Jul 10, 2018 and Apr 25, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED A KINKED CANNULA WHICH CAUSED HIGH BLOOD GLUCOSE LEVEL. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL (300 MG/DL) AND RECEIVED FLUIDS VIA INTRAVENOUS ROUTE. AFTER SPENDING 6-7 HOURS IN THE EMERGENCY ROOM, INITIALLY DISCHARGED BUT WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. PATIENT'S BLOOD GLUCOSE LEVEL WAS 230 MG/DL (STABLE) WHILE LEAVING THE EMERGENCY ROOM AND HAD KETONE LEVELS WHICH THE HEALTH CARE PROFESSIONAL ASSESSED AS DANGEROUS/LIFE THREATENING. DURING HOSPITALIZATION, PATIENT'S PUMP WAS TAKEN OFF AND WAS TREATED WITH INSULIN DRIP VIA INTRAVENOUS ROUTE AND FLUIDS WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR MORE THAN 2 DAYS AND WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8548626 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE OVER 700 MG/DL, WHICH WAS SELF-TREATED WITH A BOLUS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN DRIP. THE TREATMENT RESOLVED THE ISSUE AND BROUGHT DOWN THE BLOOD GLUCOSE LEVEL TO 430 MG/DL. THE CANNULA WAS FOUND TO BE BENT AT A 90-DEGREE ANGLE UPON REMOVAL AT THE HOSPITAL. THE PATIENT DID NOT USE THE PUMP FOR INSULIN WHILE IN HOSPITAL. 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 8534851 ↗
• InjuryFeb 8, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT WHILE IN THE EMERGENCY EXPERIENCED A BENT CANNULA WHEN THE SITE WAS REMOVED. BLOOD GLUCOSE LEVEL WAS 877 MG/DL WHEN THE PATIENT ARRIVED IN THE EMERGENCY. THE PATIENT RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT. AFTER AN HOUR IN THE EMERGENCY, THE PATIENT WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AS THE PATIENT HAD KETONE LEVELS AND THE HEALTH CARE PROFESSIONAL ASSESSED KETONE LEVELS AS DANGEROUS/LIFE THREATENING. PATIENT'S BLOOD GLUCOSE LEVEL WAS 800 MG/DL WHEN THE PATIENT WAS HOSPITALIZED AND RECEIVED BOLUS AND MANUAL INJECTION AS CORRECTIVE TREATMENT. THE TREATMENT RESOLVED THE ISSUE BUT HAD A PERMANENT DAMAGE AS THE PATIENT HAD HEART ATTACK AND STROKE LIKE SYMPTOMS DUE TO HIGH BLOOD GLUCOSE LEVEL. THE INFUSION SET WAS IN USE FOR 2 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 8319514 ↗
• InjuryJul 10, 2018Leak/Splash; No Flow

  USING AUTOSOFT:90 INSULIN INFUSION SET WITH TANDEM X2 PUMP, SET BEGAN LEAKING SO THAT INSULIN WAS NOT DELIVERED. THIS WAS ON A SET INSERTED 30 HOURS PRIOR WHICH IS INTENDED FOR USE FOR 60-72 HOURS. THE LACK OF BOLUS AND BASAL INSULIN RESULTED IN MEASURED BLOOD GLUCOSE OVER 300 FOR SEVERAL HOURS UNTIL THE INFUSION SET COULD BE REPLACED. THE SAME THING HAD HAPPENED TWICE IN THE LAST 2-3 WKS WITH THE SAME BATCH OF INFUSION SETS. THIS SAME ISSUES HAVE OCCURRED SPORADICALLY WITH THIS MODEL OF INFUSION SET OVER THE LAST FEW MONTHS. PRIOR TO USING THE AUTOSOFT:90, I HAD BEEN USING THE CLEO 90 FROM SMITHS MEDICAL. I HAD NEVER HAD A PROBLEM WITH LEAKAGE AT THE SITE. IN (B)(6) OF 2017, TANDEM CHANGED THE INFUSION SETS. THEY HAD BEEN USING STANDARD LUER LOCK CONNECTIONS FOR THE CONNECTION OF INSULIN RESERVOIR TO THE TUBING LEADING TO THE INSERTION SITE. THEY INTRODUCED THE PROPRIETARY T:LOCK CONNECTION WHICH IS NOT COMPATIBLE WITH THE LUER LOCK. THIS EFFECTIVELY LIMITED THE AVAILABLE INFUSION SETS AND ELIMINATED ALL VENDOR EXCEPT TANDEM THEMSELVES AND THEIR SUPPLIER, UNOMEDICAL. I FEEL THAT PRACTICE IS AN UNFAIR MONOPOLY THAT IS DETRIMENTAL TO CONSUMERS, PARTICULARLY IF THE ONLY SIMILAR PRODU

  Patient problems: No Information

  MAUDE report 7677295 ↗