MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEX; SUBCUTANEOUS INFUSION SET

Catalog Number 00048011811

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905)

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.Product is no longer available to be returned for evaluation.

Event Description

The caller reported that he had to go to hospital due to abscess/hematoma formation from wearing the infusion set.The caller stated that he was treated to stop the bleeding and ice was applied to the area.He was hospitalized for 1-2 hours for this incident.The caller claims that he usually gets pus and infection in the area where the cannula is inserted, but the caller never gave much importance to it.Now the cannula was inserted in the lower back and no problem was found.

• Brand Name: ACCU-CHEK ® INSIGHT FLEX
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12393446
• MDR Text Key: 268988093
• Report Number: 3011393376-2021-02670
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2021
• Device Catalogue Number: 00048011811
• Device Lot Number: 1280799
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR