MAUDE Adverse Event Report: UNOMEDICAL (SOLD BY ANIMAS) INSET INFUSION SET

Catalog Number 100-182-53

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Pain (1994); Rash (2033); Swelling (2091)

Event Date 08/09/2017

Event Type  Injury  

Event Description

This problem occurred 5 times, with 5 separate devices all from the same product lot number.Tissue was bruised when the device (insulin pump infusion set) injected under skin.There was no immediate visible bleeding into the cannula or tubing, but injection did hurt more than normal.Over the course of 2-12 hours after injecting the new infusion set, bleeding would occur under the skin and a swollen painful bump would grow in the subcutaneous tissue.The insulin mixed with the blood under the skin and was thus diluted and did not work properly.Within a few hours, my blood sugar would rise to 300-350.Since this occurred with 5 different sets that i used, my blood sugars were very elevated for a whole week, and i developed ketones in the blood and urine and got sick.

• Brand Name: INSET INFUSION SET
• Type of Device: INSET INFUSION SET
• Manufacturer (Section D): UNOMEDICAL (SOLD BY ANIMAS)
• MDR Report Key: 6806787
• MDR Text Key: 83268699
• Report Number: MW5071701
• Device Sequence Number: 1
• Product Code: OYC
• 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: 08/17/2017
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 100-182-53
• Device Lot Number: 5176690
• 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; Disability
• Patient Age: 27 YR
• Patient Weight: 74