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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S AUTO SOFT 90 23 INCH 9MM INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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UNOMEDICAL A/S AUTO SOFT 90 23 INCH 9MM INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1002819
Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506); Material Integrity Problem (2978)
Patient Problem Hyperglycemia (1905)
Event Date 01/20/2021
Event Type  Injury  
Event Description
The quality of the adhesive on the autosoft 90 infusion sets 9 mm 23 inch has deteriorated over time to make them ineffective. They are a vital part to the hybrid closed loop pancreas system by tandem. These are distributed by tandem diabetes produced by unomedical a denmark company made in mexico. It seems unomedical has a monopoly on the market. These infusion sets by not adhering to the body after all other adhesives and tapes are used , cause high blood sugar levels causing the pump and sensor delivering more wasted insulin causing potential major bodily issues. Attempts to contact unomedical and tandem diabetes have not received responses. Also, recent needle adhesive to the set upon changing has recently been observed. Causing a change in infusion sets. The bottom line is wasted of insulin, infusion sets have to be injected each time into the body and potential major health issues. Fda safety report id # (b)(4).
 
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Brand NameAUTO SOFT 90 23 INCH 9MM INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
UNOMEDICAL A/S
MDR Report Key11343963
MDR Text Key232622775
Report NumberMW5099472
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1002819
Device Catalogue Number05705244018181
Device Lot Number5314561
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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