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

Lot Number 1302949

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 08/23/2021

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.

Event Description

It was reported the customer experienced elevated blood glucose levels as a result of a bent cannula and had hyperglycemic symptoms of mild diabetic ketoacidosis and vomiting.The parent's removed the bent cannula and inserted a new head set/cannula, but were unable to lower the customer's blood glucose levels.The parent's called an ambulance and the customer was transported to the hospital.The blood glucose results and treatment provided by the emt's was not provided.At the hospital the customer was administered insulin and iv drip therapy to treat diabetic ketoacidosis.At the time of the report the patient was still hospitalized, but stable, it is unknown when they will be discharged.

• 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: 12377873
• MDR Text Key: 268482791
• Report Number: 3011393376-2021-02633
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/25/2022
• Device Lot Number: 1302949
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• 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: 24 MO