MAUDE Adverse Event Report: UNOMEDICAL A/S AUTOSOFT 90 INFUSION SET FOR TANDEM INSULIN PUMP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Material Twisted/Bent (2981); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Date 02/11/2022

Event Type  Injury  

Event Description

I use the tandem insulin pump and the autosoft 90 inserters.The infusion sets failed multiple times after working without issues for around 8 years.The cannula was bent for about 15-20 sets throughout the time frame below.Resulted in extreme high blood sugars with each failed inserter.Reported to tandem and not much action was taken.This happened between (b)(6) of 2021 to (b)(6) of 2022, until the infusion sets were changed to a different type.Tandem diabetes.Fda safety report id # (b)(4).

• Brand Name: AUTOSOFT 90 INFUSION SET FOR TANDEM INSULIN PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 14052458
• MDR Text Key: 289006267
• Report Number: MW5108833
• Device Sequence Number: 5
• 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: 04/05/2022
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DEXCOM G6; NOVOLOG; TANDEM INSULIN PUMP; ZYRTEC
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White