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

Lot Number ASKU

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

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 03/27/2022

Event Type  Injury  

Event Description

A nurse at the (b)(6) reported that the (b)(6) year old patient has been hospitalized for high blood glucose levels whilst in (b)(6) on holiday.It is unknown if the family brought the patient to the hospital or if she was taken by an ambulance.The nurse does not know which hospital the patient was at.The nurse assumed the patient's high blood glucose levels were due to an occlusion in the cannula, however due to language barrier the nurse was unsure if this message had been communicated correctly.The patient's parents tried to change the cannula, however they were inserting this manually as they didn't have the accu-chek linkassist plus insertion device with them.The cannula was not staying in the patient's body correctly, as the parents didn't ever insert the cannula manually before.In the hospital the patient's blood glucose level was measured and resulted in a value of approximately 33 mmol/l, and she was vomiting.No other symptoms were reported.At the time of this report, the patient was still in on an insulin drip in hospital (in (b)(6)); it was unconfirmed when she will be fit to leave/ be discharged.

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.Involved material is not available, as it was discarded.

• 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
• Manufacturer (Section G): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; na; pfreimd 92536 ; GM 92536
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 14038534
• MDR Text Key: 288774785
• Report Number: 3011393376-2022-01074
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/07/2022
• 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: 1 YR
• Patient Sex: Female