MAUDE Adverse Event Report: UNOMEDICAL UNDER TANDEM DIABETES/UNOMEDICAL A/S INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number VARISOFT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Hyperglycemia (1905)

Event Date 05/30/2023

Event Type  Injury  

Event Description

The tandem varisoft infusion set lot number 5388362 comes unclipped at the connector clip that connects to the clip that sticks to your body.It comes undone so easily that it has happened twice while sleeping now.My sugar is very well controlled with an ha1c of 6.2 but both times it caused my sugar to go over 400.I called the company and they sent a replacement but did not ask for the product or lot number to look into it.Others have also had this issue with the same lot number.No recall or warning has been issued.I have received another box with the same lot number and they all do the same thing.I have video to attest as well to show how typical sets hold and these come undone.Https://www.Reddit.Com/r/diabetes/comments/11m9iea/issue_with_tandem_varisoft_infusion_sets/.Reference report: mw5118200.

• Brand Name: INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL UNDER TANDEM DIABETES/UNOMEDICAL A/S
• MDR Report Key: 17078305
• MDR Text Key: 316778663
• Report Number: MW5118201
• 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: 06/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VARISOFT
• Device Catalogue Number: 1002827
• Device Lot Number: 5388362
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Patient Sequence Number: 1
• Treatment: NOVOLOG INSULIN, TANDEM INSULIN PUMP, DEXCOM G6 CONTINUOUS GLUCOSE MONITOR.; PRENATAL VITAMIN.
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic