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

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).

• Brand Name: AUTO SOFT 90 23 INCH 9MM INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 11343963
• MDR Text Key: 232622775
• Report Number: MW5099472
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002819
• Device Catalogue Number: 05705244018181
• Device Lot Number: 5314561
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 26 YR
• Patient Weight: 113