Autosoft30™ 1000200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244014602), received between Dec 26, 2018 and Jun 17, 2019 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• InjuryJun 17, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD HIGH BLOOD GLUCOSE LEVEL DUE TO MEDICATION (PREDNISONE). SHE CHANGED THE INFUSION SET 3 TIMES AS THEY DID NOT STAY ON HER BODY. HER HIGHEST BLOOD GLUCOSE LEVEL WAS 781 MG/DL. SHE CHANGED THE CARTRIDGE AND INFUSION SET IN ORDER TO RESOLVE THE ISSUE. THEREAFTER, SHE WENT TO THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE LEVEL (781 MG/DL) WHERE SHE RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. AFTER SPENDING 6 HOURS IN THE EMERGENCY ROOM, THE PATIENT WAS HOSPITALIZED. HER BLOOD GLUCOSE LEVEL HAD DROPPED (IN HIGH 300S MG/DL/LOW 400S MG/DL), AND HER CONDITION IMPROVED WHEN SHE LEFT THE EMERGENCY ROOM. DURING HOSPITALIZATION, SHE RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN THREE DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8703174 ↗
• MalfunctionMay 23, 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 STATED THAT IN ONE OF THE INFUSION SETS, THE T-LOCK WAS NOT GLUED TO THE TUBING AND CAME APART. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 300 MG/DL AT THE TIME OF THIS EVENT. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8635077 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HE WAS HOSPITALIZED BECAUSE OF BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. HIS BLOOD GLUCOSE WHEN HE ARRIVED AT THE EMERGENCY WAS ABOVE 600 MG/DL AND IT WAS STILL ABOVE 600 MG/DL WHEN HE LEFT THE EMERGENCY. THE PATIENT HAD KETONES AND THE HEALTH CARE PROFESSIONAL IDENTIFIED THE KETONE LEVEL AS DANGEROUS. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN 3 DAYS AND NO SUCH ACTIVITY WAS PERFORMED PRIOR TO THE HOSPITALIZATION. HE WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN AND THIS RESOLVED THE ISSUE. HE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT WAS HOSPITALIZED FOR 7 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 8546207 ↗
• InjuryFeb 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT THE INFUSION SET MIGHT NOT HAVE DELIVERED INSULIN PROPERLY DUE TO WHICH SHE EXPERIENCED DIABETIC KETOACIDOSIS AND WAS HOSPITALIZED. AT THE TIME OF THIS EVENT, HER BLOOD GLUCOSE LEVEL WAS AT 300 MG/DL. THE ISSUE DID NOT RESOLVE EVEN AFTER INFUSION SET CHANGE. HER HEALTH CARE PROFESSIONAL PLACED HER ON MULTIPLE DAILY INJECTION THERAPY IN ADDITION TO HER PUMP THERAPY. THERE WAS NO DAMAGE NOTICED WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8314170 ↗
• MalfunctionFeb 7, 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 SNAPPED FROM WHERE IT WAS ATTACHED TO THE SITE FROM ONE INFUSION SET. AT THE TIME OF THIS EVENT, BLOOD GLUCOSE LEVEL WAS AT 174 MG/DL. THERE WAS NO DAMAGE NOTICED WHEN THE PACKAGE WAS FIRST OPENED. THE INFUSION SET WILL BE REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8314112 ↗
• InjuryJan 30, 2019Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED AN OCCLUSION ALARM ISSUE FOR THE PAST THREE WEEKS, AS INSULIN DID NOT CAME OUT OF THE TUBING. REPORTEDLY, THERE WERE NO DROPS OF INSULIN AT THE END OF THE NEEDLE BUT HAD DROPS OF INSULIN AT THE END OF THE CARTRIDGE PIG TAIL. SHE REPORTED THAT BECAUSE OF OCCLUSIONS, SHE DID NOT RECEIVE INSULIN, WHICH LEAD TO DIABETIC KETOACIDOSIS WITH BLOOD GLUCOSE LEVEL OF 561 MG/DL. SHE SELF-TREATED WITH CONTINUOUS INSULIN THERAPY USING MDI (MULTIPLE DAILY INJECTIONS). SUBSEQUENTLY, SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. SHE RECEIVED LONG ACTING INSULIN, POTASSIUM/SALINE/FOLIC ACID INTRAVENOUSLY AS CORRECTIVE TREATMENT AND HAD BLOOD INVESTIGATIONS EVERY THREE HOURLY. SHE ALSO FELT LIKE HER EYES WERE DAMAGED AS A RESULT OF THE DEHYDRATION, HAD RETINOPATHY AND WAS UNABLE TO USE CONTACT LENSES. SHE WAS HOSPITALIZED FOR 3 DAYS. REPORTEDLY, SHE HAD USED THE INFUSION SET FOR 4 TO 5 DAYS. UNOMEDICAL RECOMMENDS MAXIMUM USE OF THE INFUSIONS BETWEEN 48-72 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8291565 ↗
• InjuryDec 26, 2018Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED ISSUES WITH INFUSION SET IN THE FORM OF BENT CANNULAS WITH BLOOD GLUCOSE LEVEL OF UP TO 380 MG/DL. SUBSEQUENTLY, SHE WAS TAKEN TO EMERGENCY ROOM (ER) AS SHE WAS NOT FEELING WELL. AT THAT TIME, HER BLOOD GLUCOSE LEVEL WAS 180 MG/DL AND HAD LARGE KETONES AS WELL. SHE WAS IN EMERGENCY ROOM FOR 3 HOURS AND RECEIVED INTRAVENOUS FLUIDS AND CORRECTION BOLUSES WITH PUMP AS CORRECTIVE TREATMENT. SHE WAS STILL NOT FEELING WELL WHEN LEFT THE ER. SHE WAS FINALLY HOSPITALIZED AFTER RECEIVING THE TREATMENT FOR HIGH BLOOD GLUCOSE (UP TO 200 MG/DL) AND KETONES. HER KETONES WERE LEVELS WERE ASSESSED AS DANGEROUS AND LIFE THREATENING. REPORTEDLY, THE PATIENT WAS USING INFUSION SET FOR TWO DAYS. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. AFTER GETTING DISCHARGED, SHE CHANGED THE SITE AND NOTICED THAT THE CANNULA WAS BENT. 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 8195210 ↗