Autosoft90™ 1000274Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244014336), received between Apr 25, 2019 and Jul 4, 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.

• InjuryJul 4, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE CHANGED HER SUPPLIES AT NIGHT AND THE NEXT DAY, SHE WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL. SHE TRIED TO GIVE HERSELF A BOLUS THROUGH HER PUMP, BUT IT DID NOT GO THROUGH DUE TO A BENT CANNULA. SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM WITH DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVEL WAS AT 470 MG/DL UPON ARRIVAL. HER LEVEL OF KETONES WAS IDENTIFIED TO BE DANGEROUS/ LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. IN THE EMERGENCY ROOM, HER BLOOD TESTS WERE PERFORMED, AND SHE WAS GIVEN INSULIN THROUGH INTRAVENOUS DRIP. SHE STAYED THERE FOR A COUPLE OF HOURS AND THEREAFTER, SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019. AS CORRECTIVE TREATMENT, SHE RECEIVED INSULIN AND FLUIDS VIA INTRAVENOUS DRIPS IN THE HOSPITAL, WHICH RESOLVED THE ISSUE. ADDITIONALLY, HER BLOOD TESTS WERE PERFORMED. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN A DAY. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2019. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8762231 ↗
• InjuryMay 31, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES . IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA ISSUE WITH THREE INFUSION SETS THAT CAUSED HIGH READING OF THE KETONES AS THE TEST WAS PERFORMED AT HOME AND ELEVATED BLOOD GLUCOSE LEVEL REPORTED TO BE 460 MG/DL AT THE TIME OF THIS EVENT. THE PATIENT CHANGED OUT INFUSION SET AND AFTER THIRD INFUSION SET CHANGE, HE DECIDED TO GO TO THE HOSPITAL. THE PATIENT WAS HOSPITALIZED WITH BORDERLINE DIABETIC KETOACIDOSIS. THE HOSPITAL MONITORED HIS BLOOD GLUCOSE LEVEL AND RAN KETONES TEST. KETONES WERE EXTRA-LARGE BY THE TIME HE REACHED THE HOSPITAL. HE WAS GIVEN INTRAVENOUS FLUIDS AND HIS FATHER CONTINUED TO DELIVER INSULIN THROUGH PUMP BUT SWITCHED INFUSION SETS, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN A DAY. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 CANNUL

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8657116 ↗
• InjuryMay 10, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUES DUE TO WHICH THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 268 MG/DL, AT THE TIME OF EVENT. THE PATIENT TRIED TO TREAT IT WITH A BOLUS AND BASAL RATE WAS CHANGED TO 1.2 UNITS. THE PATIENT ARRIVED AT THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 800 MG/DL AND STAYED THERE FOR ONE DAY. THE PATIENT'S LEVEL OF KETONES WAS ASSESED AS DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. SUBSEQUENTLY, THE PATIENT LEFT THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 800 MG/DL AND WAS HOSPITALIZED. THE PATIENT WAS STILL IN DIABETIC KETOACIDOSIS AND WAS UNCONSCIOUS. THE PATIENT RECEIVED SALINE AND INSULIN DRIP AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT HAD BEEN IN THE HOSPITAL FOR FIVE DAYS AND WAS STILL THERE AT THE TIME OF THIS REPORT. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORR

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8598111 ↗
• InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA ISSUE. THE BLOOD GLUCOSE LEVEL WAS 700 MG/DL AND THE PATIENT SELF-TREATED IT WITH A BOLUS VIA THE PUMP. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR 24 HOURS. THE PATIENT WAS HOSPITALIZED FOR TEN DAYS THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 8547887 ↗