Autosoft90™ 1000279Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244014480), received between Mar 19, 2019 and Mar 18, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS (OVER 300 MG/DL) AND KETONES. THE PATIENT CHANGED THE INFUSION SET TWO TIMES. SUBSEQUENTLY, ON (B)(6) 2020, THE PATIENT WENT TO THE HOSPITAL AFTER THE KETONES WERE NOTICED. THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS/ LIFE THREATENING. THE PATIENT WAS HOSPITALIZED DUE TO A KINKED CANNULA OF THE INFUSION SET. DURING HOSPITALIZATION THE PATIENT RECEIVED INFUSION KALIUM AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. ON (B)(6) 2020, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. MOREOVER, ON (B)(6) 2021, THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS WHICH WAS DUE TO A KINKED CANNULA AND THE PATIENT WAS HOSPITALIZED FOR FOUR 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 11511521 ↗
• InjuryAug 5, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNRESPONSIVE TO THE PUMP INSULIN DELIVERY. FURTHERMORE, IT WAS MENTIONED THAT HIS BLOOD GLUCOSE LEVEL HAD BEEN A BIT HARDER TO CONTROL AND HE ALSO HAD A SURGERY RECENTLY. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH HE TRIED TO TREAT BY DELIVERING BOLUSES THROUGH PUMP AND MANUAL INJECTIONS. ON THE SAME DAY, THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL AND HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS MORE THAN 600 MG/DL. THE PATIENT RECEIVED LANTUS AND SHOTS AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR ONE DAY AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. AT THE TIME OF THIS REPORT, HE WAS STILL IN THE HOSPITAL. AFTER TROUBLESHOOTING, IT WAS FOUND THAT THE CANNULA WAS BENT AND WAS THE CAUSE OF HIGH BLOOD GLUCOSE LEVEL. THE PATIENT WAS ADVISED TO PUT ON ALL NEW SUPPLIES SINCE THE CURRENT ONES WERE A WEEK OLD. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF IN

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8858564 ↗
• InjuryAug 5, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT ON (B)(6) 2019, HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND THE PATIENT TOOK 4-5 UNITS OF INJECTION, WHICH RESOLVED THE HIGH BLOOD GLUCOSE LEVEL ISSUE. ON (B)(6) 2019, WHEN THE PATIENT WOKE UP, HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH HE WAS UNABLE TO ADDRESS. SUBSEQUENTLY, HE WAS RUSHED TO THE EMERGENCY ROOM VIA AMBULANCE, WHERE HE RECEIVED AN UNSPECIFIED DRIP VIA INTRAVENOUS ROUTE BY NURSES. THE PATIENT LEFT THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 575 MG/DL. ON THE SAME DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL. WHILE IN THE HOSPITAL, THE PATIENT REMOVED THE INFUSION SET AND HE NOTICED THAT THE CANNULA WAS BENT, WHICH WAS THE SUSPECTED CAUSE OF HIGH BLOOD GLUCOSE LEVEL ACCORDING TO THE PATIENT. DURING HOSPITALIZATION, HE RECEIVED AN INTRAVENOUS DRIP, WHICH RESOLVED THE ISSUE. HE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED, AND THE INFUSION HAD BEEN IN USE FOR THREE DAYS. ON (B)(6) 2019, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. UNOMEDICAL DO NOT SEE BENT/KINKING AS B

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8858548 ↗
• InjuryJul 19, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HE HAD ISSUES WITH THE PUMP, WHICH STARTED AROUND (B)(6) 2019 AS HE WAS NOT GETTING INSULIN PROPERLY. HIS BLOOD GLUCOSE LEVEL WAS NOT RESPONDING OR BEING CONTROLLED, UNLESS HE GAVE HIMSELF A MANUAL INJECTION. THE PATIENT'S HIGHEST BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 750 MG/DL. AT TIMES, HE CHANGED HIS TEMPORARY BASAL RATE FROM 50%/50% TO 100% TO RESOLVE HIS HIGH BLOOD GLUCOSE LEVEL ISSUE. ON THE SAME DAY, THE PATIENT WENT INTO DIABETIC KETOACIDOSIS AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HIMSELF DID NOT OBSERVE THE CANNULA BUT HIS TEAM OF DOCTORS STATED THAT IT WAS BENT, WHICH WAS THE SUSPECTED CAUSE OF HIS HIGH BLOOD GLUCOSE LEVEL. AS CORRECTIVE TREATMENT, THE PATIENT WAS PUT ON INSULIN DRIP AND THE PUMP WAS REMOVED FROM HIM, WHICH RESOLVED THE ISSUE. HOWEVER, HE STATED THAT BECAUSE OF DIABETIC KETOACIDOSIS, HE HAD A HEART ATTACK AND HAD TO HAVE STENTS PUT IN HIS HEART. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN THREE DAYS. ON (B)(6) 2019, THE PATIENT WAS RELEASED FROM THE HOSPITAL. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRA

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8806452 ↗
• InjuryJun 21, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH SHE TRIED TO SELF-TREAT WITH A CORRECTION BOLUS AND BY REPLACING HER INFUSION SET SUPPLIES. THEREAFTER, THE PATIENT HAD TO GO TO THE EMERGENCY ROOM DUE TO ELEVATED BLOOD GLUCOSE LEVEL CAUSED BY THREE KINKED INFUSION SET SITES IN THE PAST 24 HOURS LEADING TO THE EMERGENCY ROOM VISIT. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS IN 700S MG/DL AT THE TIME OF ARRIVAL AND THE PATIENT'S LEVEL OF KETONES WAS ASSESSED TO BE DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. THE PATIENT RECEIVED INSULIN DRIP AND FLUIDS IN THE EMERGENCY ROOM. SHE STAYED THERE FOR FOUR HOURS AND WAS SUBSEQUENTLY HOSPITALIZED WITH BLOOD GLUCOSE LEVEL IN 500S MG/DL. THE STAFF AT THE HOSPITAL WAS UNDER THE IMPRESSION THAT SHE MIGHT HAVE HAD A HEART ATTACK. IN THE HOSPITAL, SHE RECEIVED INSULIN AND BLOOD THINNERS AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN ONE DAY. SHE STAYED IN THE HOSPITAL FOR FOUR DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8721249 ↗
• MalfunctionApr 18, 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 INFUSION SET TUBING DISCONNECTED FROM THE SITE AND THE TUBING PULLED OUT FROM THE CONNECTOR LEAD AND THIS ISSUE OCCURRED WITH TWO INFUSION SETS. PATIENT'S BLOOD GLUCOSE LEVEL WAS ABOVE 300 MG/DL AT THE TIME OF BOTH THE INCIDENTS. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8526626 ↗
• InjuryMar 19, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED HAVING KINKED CANNULA AND NO INSULIN DELIVERY ISSUES WITH ONE INFUSION SET. AT THE TIME OF THIS EVENT, PATIENT'S BLOOD GLUCOSE LEVEL WAS 590 MG/DL AND THE PATIENT ALSO HAD HIGH LEVEL OF KETONES THAT WAS ASSESSED AS DANGEROUS BY A HEALTHCARE PROFESSIONAL. DUE TO THIS, THE PATIENT REMOVED THE KINKED CANNULA AND SELF-TREATED WITH INSULIN VIA INTRAVENOUS ROUTE. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE THE PATIENT RECEIVED INSULIN VIA INTRAVENOUS ROUTE, 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. 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 8435152 ↗