Autosoft90™ 1002822Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 05705244018273), received between Dec 17, 2021 and Aug 6, 2026 — classified as 2 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (49 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152265 ↗
• MalfunctionAug 4, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125197 ↗
• MalfunctionAug 4, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125187 ↗
• InjuryApr 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT FACED ADHESIVE PATCH AND CANNULA HOUSING DETACHED FROM SPRING PRIOR TO INSERTION ON (B)(6) 2026. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND RECEIVED TREATMENT WITH CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY.

  Patient problems: Hyperglycemia

  MAUDE report 24753275 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT HAS ISSUE WITH AN INFUSION SET LEAKING AT THE SITE AFTER ABOUT TWENTY HOURS OF USE ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713271 ↗
• MalfunctionMar 21, 2026Loss of or Failure to Bond; Premature Separation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET ADHESIVE ISSUE EVENT ON (B)(6) 2026. THE INFUSION SET FELL OFF DURING USE WITHIN 10 MINUTES. THE ISSUE OCCURRED WITH TWO INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24657996 ↗
• MalfunctionMar 21, 2026Loss of or Failure to Bond; Premature Separation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET ADHESIVE ISSUE EVENT ON (B)(6) 2026. THE INFUSION SET FELL OFF DURING USE WITHIN 10 MINUTES. THE ISSUE OCCURRED WITH A TOTAL OF FOUR INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24657994 ↗
• MalfunctionMar 17, 2026Loss of or Failure to Bond; Premature Separation

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUE WITH THREE INFUSION SETS ON (B)(6) 2026 AS THE INFUSION SET PATCH DID NOT STICK TO THE SKIN UPON INSERTION. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615494 ↗
• MalfunctionMar 17, 2026Loss of or Failure to Bond; Premature Separation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUE WITH THREE INFUSION SETS ON (B)(6) 2026 AS THE INFUSION SET PATCH DID NOT STICK TO THE SKIN UPON INSERTION. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615491 ↗
• MalfunctionMar 17, 2026Loss of or Failure to Bond; Premature Separation

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUE WITH THREE INFUSION SETS ON (B)(6) 2026 AS THE INFUSION SET PATCH DID NOT STICK TO THE SKIN UPON INSERTION. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615484 ↗
• MalfunctionFeb 11, 2026Deformation Due to Compressive Stress

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 24311709 ↗
• MalfunctionFeb 11, 2026Deformation Due to Compressive Stress

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 24311697 ↗
• MalfunctionFeb 11, 2026Deformation Due to Compressive Stress

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 24311696 ↗
• MalfunctionNov 3, 2025Device Handling Problem; Device Handling Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 23449432 ↗
• MalfunctionSep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHEMENT EVENT ON (B)(6) 2025. THE TUBING WAS DETACHED AT SITE CONNECTOR. INFUSION SET WAS USED FOR 3 TO 7 HOURS. BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 23071932 ↗
• MalfunctionAug 8, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SETS TUBING BLOCKAGE EVENTS BETWEEN (B)(6) 2025. THE INFUSION SETS WERE IN USE FOR SOMETIMES FOR ONE DAY AND SOMETIMES FOR A COUPLE HOURS FOR EVERY EVENTS. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENTS AND THE PATIENT GOT TREATED WITH CORRECTION BOLUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 22746687 ↗
• MalfunctionAug 8, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS EMDR IS BEING SUBMITTED FOR UNKNOWN NUMBER QUANTITY. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SETS TUBING BLOCKAGE EVENTS BETWEEN (B)(6) 2025.THE INFUSION SETS WERE IN USE FOR SOMETIMES FOR ONE DAY AND SOMETIMES FOR A COUPLE HOURS FOR EVERY EVENTS. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENTS AND THE PATIENT GOT TREATED WITH CORRECTION BOLUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 22746686 ↗
• MalfunctionAug 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711071 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025 TO (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076142 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025 TO (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076140 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076139 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076138 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076137 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025 TO (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076136 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVEN EVENTS WHERE THE INFUSION SET TUBING WAS LEAKING AT COUPLING HOUSING FROM (B)(6) 2025. THE INFUSION SET WAS IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076135 ↗