Autosoft30™ 007287Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244004610), received between Apr 16, 2019 and Apr 24, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 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 SHE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL, WHICH WAS SELF-TREATED WITH THE PUMP. SUBSEQUENTLY, THE PATIENT WENT TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL OVER 700 MG/DL AND SHE WAS PUT ON AN INSULIN DRIP. THE PATIENT ALSO HAD LARGE KETONES, WHICH WAS ASSESSED AS DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. HER BLOOD GLUCOSE LEVEL WAS IN 200 MG/DL RANGE AND SHE WAS STILL NOT FEELING WELL WHEN SHE LEFT THE EMERGENCY ROOM. SO, SHE WAS ADMITTED TO THE HOSPITAL AND WAS PUT ON AN INSULIN DRIP, WHICH RESOLVED PATIENT'S HIGH BLOOD GLUCOSE LEVEL. THE INFUSION SET WAS IMPROPERLY INSERTED A DAY BEFORE HOSPITALIZATION AND IT HAD BEEN IN USE FOR LESS THAN A DAY. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND 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 SLIG

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8542952 ↗
• InjuryApr 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ADHESIVE SET ISSUES. THE INFUSION SITE FELL OFF THE PATIENT'S BODY OVERNIGHT. REPORTEDLY, THE BLOOD GLUCOSE WAS 400 MG/DL AT THE TIME OF THIS EVENT AS SHE DID NOT RECEIVE BASAL OR CORRECTION BOLUSES. ALTHOUGH, SHE DID ADMINISTER CORRECTION BOLUSES BEFORE SHE REALIZED THAT THE SITE WAS NOT ON HER BODY. SO, SHE PLACED A NEW SITE FOR THE RESOLUTION OF THIS ISSUE. SHE WAS TAKEN TO THE EMERGENCY ROOM AND STAYED THERE FOR TWO HOURS WHERE INTRAVENOUS INSULIN DRIP WAS GIVEN. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL IN THE INTENSIVE CARE UNIT BECAUSE OF HIGH BLOOD GLUCOSE LEVELS AND WAS HOSPITALIZED FOR TWO DAYS. DURING HOSPITALIZATION, SHE RECEIVED INTRAVENOUS INSULIN DRIP. IT WAS REPORTED THAT SHE REVERTED TO MULTIPLE DAILY INJECTION, BUT HER BLOOD GLUCOSE WAS STILL IN THE RANGE OF 200-250 MG/DL. THE INFUSION SET WAS USED FOR ONE AND A HALF DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517243 ↗