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

Lot Number 5320590

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 07/22/2021

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

According to the customer's allegation, on the incident day the user of the accu-chek flexlink experienced a hyperglycemic episode.On (b)(6) 2021 at 07:00 am the customer inserted a new acannula that seemed to be inserted correctly.At 12:00pm the customer experienced elevated blood glucose symptoms of feeling bad and vomiting.The customer checked his blood glucose and received a result of 400 mg/dl.The user's daughter immediately transported him to the hospital.The health care professional and the nurse of the hospital informed the customer, that the problem came from the headset needle, that had folded/bent inside the customer's body.The user confirmed that there was no leakage from the cannula.The hospital treated the customer with unknown insulin to lower blood glucose levels.The customer was discharged from the hospital on (b)(6) 2021.

• Brand Name: ACCU-CHEK ® FLEXLINK INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12246119
• MDR Text Key: 264084641
• Report Number: 3011393376-2021-02292
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2022
• Device Lot Number: 5320590
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• 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: 46 YR