MAUDE Adverse Event Report: TANDEM / UNOMEDICAL DEVICES S.A. DE C.V. AUTOSOFT 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 5262078

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2019

Event Type  Injury  

Event Description

Cannula of infusion set gets folded over due to residual torque and or bad nesting in insertion device.Lack of insulin delivery.Fda safety report id# (b)(4).

• Brand Name: AUTOSOFT 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TANDEM / UNOMEDICAL DEVICES S.A. DE C.V.
• MDR Report Key: 8631778
• MDR Text Key: 145898503
• Report Number: MW5086800
• 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: 05/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Lot Number: 5262078
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 77