Autosoft90™ 005910Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05705244004450), received between Mar 22, 2019 and Nov 5, 2019 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED BY THE PATIENT'S SISTER THAT THE PATIENT FACED BENT CANNULA ISSUE WHICH LED TO INCREASED BLOOD GLUCOSE LEVELS. AT THE TIME OF THE EVENT, (WHICH OCCURRED 2 WEEKS AGO) THE BLOOD GLUCOSE LEVEL WAS 600 MG/DL, WHICH THE PATIENT TRIED TO TREAT WITH A CORRECTION BOLUS. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM, WHERE KETONES WERE DETERMINED TO BE HIGH, AND THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS/LIFE THREATENING. THE PATIENT ARRIVED IN THE EMERGENCY ROOM, WITH A BLOOD GLUCOSE LEVEL OF APPROXIMATELY 600 MG/DL, STAYED THERE FOR A FEW HOURS AND WAS ADMINISTERED INJECTIONS OF INSULIN AND INTRAVENOUS DRIP (DRUG NAME UNKNOWN). FURTHER, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 600 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS, WHEN LEFT THE EMERGENCY ROOM. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND RECEIVED MANUAL INJECTIONS AND MEDICATION INTRAVENOUSLY (DRUG NAME UNKNOWN), WHICH RESOLVED THE ISSUE. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER TWO DAYS AND HAD NO PERMANENT DAMAGE. MOREOVER, THERE WAS NO DAMAGE WHEN THE PACKAGE WAS FIRST OPENED,

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9277045 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE WAS NOT RECEIVING INSULIN DUE TO A BENT CANNULA THAT LED TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. HER BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS ABOVE 500 MG/DL AND THE INFUSION SET HAD BEEN IN USE FOR 1 DAY. SHE WAS GIVEN A METERED DOSE INHALER IN AN ATTEMPT TO RESOLVE THE ISSUE. NO ACTIVITY WAS PERFORMED PRIOR TO HOSPITALIZATION. THE PATIENT RECEIVED INTRAVENOUS AND MDI AS A PART OF TREATMENT AND THIS RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR 4 DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OFINSERTION 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 8543384 ↗
• InjuryApr 24, 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 500 MG/DL, AT THE TIME OF INCIDENT AND THE PATIENT TRIED TO SELF-TREAT IT WITH A BOLUS USING THE PUMP. SHE WAS UNAWARE THAT HER BLOOD GLUCOSE LEVEL HAD ELEVATED UNTIL PARAMEDICS ARRIVED AT HER HOME. THEY REMOVED THE INFUSION SET AND SAW THAT THE CANNULA WAS BENT DUE TO WHICH THE PATIENT WAS NOT RECEIVING INSULIN. SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, LOW BLOOD PRESSURE AND URINARY TRACK INFECTION DUE TO WHICH SHE WAS ADMITTED TO THE HOSPITAL. THE PATIENT ALSO HAD KETONES AND ITS LEVEL WAS IDENTIFIED TO BE DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. SHE RECEIVED INTRAVENOUS DRIP IN THE HOSPITAL, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. THE PATIENT FACED BENT CANNULA ISSUE WITH THREE INFUSION SETS. THE PATIENT HAD NOT NOTICED ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND SHE STAYED IN THE HOSPITAL FOR SIX 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8543115 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S CANNULA WAS BENT. REPORTEDLY, SHE HAD HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL AND DIABETIC KETOACIDOSIS WHICH LED TO A MINOR HEART ATTACK AND SUBSEQUENTLY HOSPITALIZATION. PRIOR TO HOSPITALIZATION, SHE SELF-TREATED WITH A BOLUS. IT WAS STATED THAT THE BENT CANNULA WAS NOTICED WHEN SHE REMOVED SITE FOR OBSERVATION WHILE AT HOSPITAL. DURING HOSPITALIZATION, SHE RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. IT WAS NOTICED THAT MINIMAL TISSUE DEATH IN HEART HAD OCCURRED DUE TO MINOR HEART ATTACK AND NO OTHER PERMANENT DAMAGE WAS SEEN. THE INFUSION SET WAS USED FOR LESS THAN 24 HOURS. SHE WAS HOSPITALIZED 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 8543065 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT HE HAD AT LEAST ONE KINKED CANNULA FROM EVERY BOX HE HAD USED SINCE HE STARTED USING THE PUMP WITH A TOTAL OF AT LEAST 10 INFUSION SETS AFFECTED. THERE WERE TWO DIFFERENT OCCASIONS WHERE HE ENDED UP BEING HOSPITALIZED DUE TO A KINKED CANNULA. THE FIRST TIME, HE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL DUE TO A KINKED CANNULA, WHICH HE SELF-TREATED WITH A CORRECTION BOLUS. HE STATED THAT HE HAD CHANGED HIS CARTRIDGE, TUBING AND SITE LESS THAN 24 HOURS PRIOR TO GOING INTO DIABETIC KETOACIDOSIS. HE WAS TAKEN TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 1026 MG/DL WHERE HE WAS GIVEN AN INSULIN DRIP AND STAYED THERE FOR THREE HOURS. THE LEVEL OF KETONES WAS IDENTIFIED TO BE DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE PATIENT RECEIVED AN INSULIN DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN 24 HOURS AND THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER FOUR DAYS. THE SECOND TIME, THE PATIENT HAD CHEST PAINS AND HIGH BLOOD GLUCOSE LEVEL, WHICH WAS SELF-TREATE

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8543044 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET CANNULA WAS KINKED. REPORTEDLY, HIS BLOOD GLUCOSE LEVEL WAS OVER 700 MG/DL, EXPERIENCED DIABETIC KETOACIDOSIS WHICH HE SELF-TREATED WITH A CORRECTION BOLUS. SUBSEQUENTLY, HE WAS ADMITTED TO THE HOSPITAL AND WAS GIVEN INSULIN DRIP AND LANTUS (INSULIN GLARGINE) WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR ONE DAY. HE WAS HOSPITALIZED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO HIM. MOREOVER, THIS WAS THE SECOND TIME THAT HE WAS ADMITTED INTO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS THAT WEEK. 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 8542813 ↗
• 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 THE SITE GOT REMOVED DURING THE NIGHT DUE TO AN ADHESIVE ISSUE. SHE WAS ILL AND WOKE UP IN THE MORNING, THROWING UP AND WITH HIGH BLOOD GLUCOSE LEVEL. SUBSEQUENTLY, SHE WAS TAKEN TO THE EMERGENCY ROOM WHERE SHE RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN DRIP AS CORRECTIVE TREATMENT. AFTER SPENDING FEW HOURS IN THE EMERGENCY ROOM, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT DUE TO DIABETIC KETOACIDOSIS. SHE HAD KETONE LEVEL WHICH THE HEALTH CARE PROFESSIONAL ASSESSED AS DANGEROUS/LIFE THREATENING. SHE RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN DRIP, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE WAS HOSPITALIZED FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8534912 ↗
• InjuryApr 16, 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 HE ACCIDENTALLY RIPPED OFF HIS SITE, WENT BACK HOME TO REPLACE THE SITE BUT LATER DISCOVERED THE CANNULA WAS NOT INSERTED ALL THE WAY INTO HIS SKIN AND WAS KINKED. HE HAD HIGH BLOOD GLUCOSE LEVEL OF 798 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS, SO WAS ADMITTED TO THE HOSPITAL. DURING HOSPITALIZATION, HE RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS ADMITTED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517147 ↗
• MalfunctionApr 15, 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 TUBING WAS NOT CONNECTED TO THE SITE WHILE SHE UNWOUND IT. THE BLOOD GLUCOSE WAS 206 MG/DL AT THE TIME OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8513244 ↗
• MalfunctionApr 10, 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 UPON UNWINDING THE TUBING, IT GOT DISCONNECTED FROM THE SITE. SHE NOTICED DISCONNECTED TUBING AFTER PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8498298 ↗
• MalfunctionMar 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT'S PUMP FELL OUT OF HER POCKET, CAUSING THE TUBING TO SNAP AND HER BLOOD GLUCOSE LEVEL WAS 224 MG/DL AT THE TIME OF EVENT. PATIENT'S INFUSION SET WAS CHANGED OUT. 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 8467970 ↗
• InjuryMar 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED HAVING MULTIPLE CRIMPED CANNULA ISSUES WITH 15 INFUSION SETS. HE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS OVER 600 MG/DL. HE ALSO HAD HIGH LEVEL OF KETONES, WHICH WAS IDENTIFIED AS DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. THE PATIENT TOOK CORRECTIVE BOLUS AND MULTIPLE DOSE INJECTION THERAPY TO RESOLVE THE BLOOD GLUCOSE ISSUE. SUBSEQUENTLY, HE WAS ADMITTED TO THE HOSPITAL WHERE HE RECEIVED INSULIN DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY TWO DAYS. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. HE WAS RELEASED FROM THE HOSPITAL AFTER THREE DAYS. AT THE TIME OF THIS REPORT, PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 360 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8442894 ↗