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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V AUTOSOFT 30; SET, ADMINISTRATION, INTRAVASCULAR
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UNOMEDICAL DEVICES S.A DE C.V AUTOSOFT 30; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Patient Problem Hyperglycemia (1905)
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: mw5154143, mw5154144.
 
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Brand Name
AUTOSOFT 30
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
UNOMEDICAL DEVICES S.A DE C.V
MDR Report Key19172360
MDR Text Key341134668
Report NumberMW5154145
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Patient Sequence Number1
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 Age69 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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