Autosoft90™ 005908Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05705244004412), received between Feb 19, 2019 and Jul 19, 2019 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 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 INFUSION SET'S TUBING DETACHED FROM THE INFUSION SET APPLICATOR. ON THE DAY OF THIS REPORT, THE PATIENT ATE FOOD SINCE THE PATIENT NOTICED THAT BLOOD GLUCOSE LEVEL WAS LOW (47 MG/DL). THE PATIENT SUCCESSFULLY CHANGED OUT THE INFUSION SET AND RESUMED INSULIN THERAPY. 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 8806309 ↗
• InjuryMay 10, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD CHANGED HER SUPPLIES AT NIGHT AND WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 518 MG/DL, AT THE TIME OF THIS EVENT. THE PATIENT SELF-TREATED WITH A BOLUS AND A MANUAL INJECTION. WHILE CHANGING HER SITE, SHE NOTICED A KINKED CANNULA. SHE CHANGED HER SITE AND HER BLOOD GLUCOSE LEVEL DID NOT STABILIZE. THEREAFTER, SHE REMOVED THE SITE TO FIND THE CANNULA HAD BENT A SECOND TIME. THE PATIENT CHANGED HER SITE AGAIN AND HER BLOOD GLUCOSE LEVEL STILL DID NOT STABILIZE. SO, SHE WENT TO THE EMERGENCY ROOM FOR A FEW HOURS WITH BLOOD GLUCOSE LEVEL AT 518 MG/DL AND RECEIVED INTRAVENOUS TREATMENT OF FLUIDS AND INSULIN. THE PATIENT HAD HIGH BLOOD PRESSURE, TACHYCARDIA AND HER KETONE LEVEL WAS ASSESSED AS DANGEROUS/LIFE THREATENING BY A HEALTH CARE PROFESSIONAL. SUBSEQUENTLY, HER CONDITION WAS UNSTABLE, AND SHE WAS ADMITTED TO THE HOSPITAL FOR DIABETIC KETOACIDOSIS. WHEN THE SITE WAS REMOVED THEY FOUND THE THIRD SITE HAD BENT INSIDE HER BODY AS WELL. DURING HOSPITALIZATION, SHE RECEIVED INSULIN AND FLUID VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8598265 ↗
• InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT SHE HAD FACED BENT CANNULA. REPORTEDLY, HER BLOOD GLUCOSE WAS RAISED, AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SHE WENT TO THE EMERGENCY AND STAYED THERE FOR A FEW HOURS WHERE SHE RECEIVED INTRAVENOUS INSULIN DRIP AND SOME UNSPECIFIED FLUIDS. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL, WHEN SHE ARRIVED AT THE EMERGENCY ROOM WAS AND IT ELEVATED TO 600 MG/DL WHILE SHE WAS IN THE EMERGENCY ROOM. SHE WAS SICK, THOUGHT THAT HER CANNULA WAS BENT AND STATED THAT THE KETONE LEVELS WERE DANGEROUS. SHE WAS STABLE, WHEN SHE LEFT THE EMERGENCY ROOM. SUBSEQUENTLY, SHE WAS ADMITTED TO THE REGULAR FLOOR, WHERE SHE WAS TREATED WITH SOME UNSPECIFIED FLUIDS AND INSULIN DRIP THROUGH A SYRINGE WHICH RESOLVED THE ISSUE AFTER A FEW DAYS. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND 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 FU

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8547929 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED SYMPTOMS OF DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL, WHICH HE ATTEMPTED TO TREAT WITH A CORRECTION BOLUS. HE TOOK A DINNER BOLUS AS WELL PRIOR TO EXPERIENCING DIABETIC KETOACIDOSIS. SUBSEQUENTLY, HE WENT TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 808 MG/DL, WHICH WAS TREATED WITH INSULIN THROUGH INTRAVENOUS ROUTE. WHEN HE LEFT THE EMERGENCY ROOM AFTER SIX HOURS, HIS BLOOD GLUCOSE LEVEL WAS AT 600 MG/DL AND HIS CONDITION WAS STABLE. HOWEVER, HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER TREATMENT. IN THE HOSPITAL, THE HEALTHCARE PROFESSIONALS SAW THAT HE HAD A BENT CANNULA. HE RECEIVED INSULIN VIA INTRAVENOUS ROUTE AND MAGNESIUM AS CORRECTIVE TREATMENT IN THE HOSPITAL, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS AND THE PATIENT STAYED IN THE HOSPITAL FOR FOUR 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 FLEXI

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8543316 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED EXTREMELY HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 1200 MG/DL AS HE HAD UNDERLYING MEDICAL PROBLEMS, USED A TUBING FEED AND HAD A CANNULA BENT IN HALF. THE PATIENT TRIED TO SELF-TREAT IT WITH A CORRECTIVE BOLUS. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE HE RECEIVED INSULIN VIA DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS AND THE PATIENT STAYED IN THE HOSPITAL FOR APPROXIMATELY SEVEN 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 8543262 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S CANNULA WAS BENT AT THE INFUSION SITE. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE WAS ABOVE 600 MG/DL AND HAD EXPERIENCED DIABETIC KETOACIDOSIS. THE PATIENT SELF-TREATED WITH INSULIN VIA INJECTION. SUBSEQUENTLY, THE PATIENT WENT TO THE EMERGENCY ROOM FOLLOWED WITH HOSPITALIZATION WHERE INSULIN DRIP AND SOME UNSPECIFIED INTRAVENOUS FLUIDS WERE GIVEN WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND 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 8538783 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED KINKED CANNULA ISSUES THRICE THAT RESULTED IN HIGH BLOOD GLUCOSE LEVEL EACH TIME. THE FIRST TIME, THE PATIENT ALSO EXPERIENCED DIABETIC KETOACIDOSIS SYMPTOMS AND SELF-TREATED IT WITH A MANUAL INJECTION. THE PATIENT ARRIVED AT THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 700 MG/DL. SHE RECEIVED INTRAVENOUS PLACEMENT AND STAYED THERE FOR A FEW HOURS BEFORE GETTING TRANSFERRED TO THE INTENSIVE CARE UNIT AS HER CONDITION WAS UNSTABLE. THREE WEEKS LATER, SHE AGAIN EXPERIENCED DIABETIC KETOACIDOSIS SYMPTOMS AND TOOK A CORRECTION BOLUS WITH THE PUMP ALONG WITH MULTIPLE DAILY INJECTIONS. SHE WENT TO THE EMERGENCY ROOM WHERE SHE RECEIVED INTRAVENOUS PLACEMENT AND STAYED THERE FOR A FEW HOURS BEFORE GETTING TRANSFERRED TO THE INTENSIVE CARE UNIT AS HER CONDITION WAS UNSTABLE. A MONTH AND A HALF BEFORE THIS REPORT, THE PATIENT AGAIN EXPERIENCED DIABETIC KETOACIDOSIS SYMPTOMS AND WAS TAKEN TO THE EMERGENCY ROOM. SHE WAS GIVEN INTRAVENOUS PLACEMENT AND A SHOT FOR CHEST PAIN. SHE STAYED IN THE EMERGENCY ROOM FOR SEVEN HOURS BEFORE GETTING TRANSFERRED TO THE INTENSIVE CARE UNIT AS HER CONDITION WAS UNSTAB

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8538719 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED KINKED CANNULA ISSUE DUE TO WHICH INSULIN WAS NOT GETTING DELIVERED TO HER. HER BLOOD GLUCOSE LEVEL ELEVATED INTO A HIGH RANGE REPORTEDLY OVER 600 MG/DL, WHICH WAS SELF-TREATED WITH A BOLUS. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL WHERE SHE RECEIVED INSULIN THERAPY AND FLUIDS VIA INTRAVENOUS ROUTE. THEREAFTER, PATIENT'S BLOOD GLUCOSE LEVEL LOWERED TO 129 MG/DL. LOWEST REPORTED DECLINE WAS TO 73 MG/DL. THE INFUSION SET HAD BEEN IN USE FOR THREE DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE 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 8538667 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS CAUSED BY A KINKED CANNULA. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS AND WAS RELEASED IN A STABLE CONDITION. 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 8538563 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT PULLED THE SITE OUT AND THE CANNULA WAS FOUND TO BE COMPLETELY KINKED. DUE TO THIS, THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 540 MG/DL. THE PATIENT SELF-TREATED IT BY DELIVERING BOLUSES USING THE PUMP. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE THE PATIENT RECEIVED INSULIN AND SALINE VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR ONE AND A HALF DAYS. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT HAD STAYED IN THE HOSPITAL FOR TWO 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 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 8538520 ↗
• InjuryApr 23, 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 DUE TO WHICH HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE OVER 500 MG/DL. HIS SUPPLIES WERE CHANGED OUT, AND HE WAS GIVEN A BOLUS. HE ALSO HAD KIDNEY ISSUES AND A HEART ATTACK. SUBSEQUENTLY, HE WAS ADMITTED TO THE HOSPITAL WHERE HE RECEIVED INSULIN VIA INTRAVENOUS DRIP, HEART OPERATION TO INSERT A STENT AND POSSIBLE DIALYSIS, WHICH RESOLVED THE ISSUE. THE PATIENT WAS ABOUT TO BE RELEASED WHEN HE ACCIDENTALLY INJECTED SOME INSULIN FROM A 300-UNIT TANDEM SYRINGE DIRECTLY INTO HIS BODY. THEREFORE, HE REMAINED IN THE HOSPITAL AS THEY WERE UNSURE HOW MUCH INSULIN HE RECEIVED. THE PATIENT STAYED IN THE HOSPITAL FOR TEN 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 8538502 ↗
• 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 WAS REPORTED, THAT WHILE SLEEPING, THE PATIENT'S INFUSION SET CAME APART AT THE CONNECTOR. THE BLOOD GLUCOSE, AT THE TIME OF THIS EVENT WAS 296 MG/DL. THERE WAS NO DAMAGE REPORTED WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8494327 ↗
• MalfunctionApr 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET TUBING CAME UNGLUED FROM THE CONNECTOR PIECE THAT CLIPPED INTO THE SITE WHILE SHE WAS SLEEPING LAST NIGHT. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 140 MG/DL AND SHE 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 8472173 ↗
• MalfunctionMar 28, 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 INFUSION SET'S TUBING HAD DETACHED FROM THE INFUSION SITE. THE FORK SHAPED PLASTIC CONNECTOR PIECE REMAINED CONNECTED TO THE INFUSION SITE. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THIS EVENT WAS 296 MG/DL, WHICH WAS TREATED WITH INSULIN DELIVERY VIA INJECTION. AS A RESULT OF OVER CORRECTING, PATIENT'S BLOOD GLUCOSE LEVEL DROPPED DOWN TO 56 MG/DL. THE PATIENT ATE CORN FLAKES TO CORRECT IT. 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 8462896 ↗
• InjuryFeb 19, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE WHICH LED TO HIGH BLOOD GLUCOSE. SHE SELF-TREATED IT WITH A CORRECTION BOLUS WITH THE PUMP AND ALSO REPLACED THE INFUSION SET. REPORTEDLY, THE BLOOD GLUCOSE WAS AROUND 500 MG/DL BEFORE SHE LEFT HOME AND WAS 274 MG/DL ON ARRIVAL AT EMERGENCY WHERE SHE WAS FOR ONE DAY AND RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. WHEN SHE LEFT THE EMERGENCY ROOM, SHE FELT SICK AND HER BLOOD GLUCOSE WAS BETWEEN 100-300 MG/DL AND WAS HOSPITALIZED SUBSEQUENTLY. THE PATIENT STATED SHE WAS DISCHARGED FROM THE HOSPITAL AFTER 2 NIGHTS. 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 8349491 ↗