MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V AUTOSOFT 30; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1002825

Patient Problem Hyperglycemia (1905)

Event Date 04/21/2024

Event Type  malfunction  

Event Description

I use a tandem t-slim insulin pump.I use autosoft 30 infusion sets.I started having problems with infusion set failures a few months ago but did not realize that some of the infusion sets were defective.On two occasions i had very high blood glucose levels because i did not realize the infusion sets were an issue.I reported the problem to tandem on two occasions but they have not fixed the issue.Today as i was changing my infusion set, i noticed yet again that i had a faulty set.Specifically, the guiding needle that introduces the cannula under my skin, was recessed into the cannula by several millimeters, making the infusion set unusable.Tandem pumps should be addressing this problem.Defective infusion sets lead to serious episodes of hyperglycemia and dka (diabetic keto acidosis).Reference reports: mw5154144, mw5154145.

• Brand Name: AUTOSOFT 30
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A DE C.V
• MDR Report Key: 19172249
• MDR Text Key: 341135373
• Report Number: MW5154143
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1002825
• Device Lot Number: 6004147
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 10MG.; ELIQUIS 5MG.; ESTRADIOL 1MG.; HUMALOG BY PUMP.; MONTELUKAST SODIUM 10MG.; PROGESTERONE 100MG.; SYNTHROID 150MCG.; TANDEM T-SLIM PUMP.; VALSARTAN 160MG.; VITAMIN D.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White