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

Lot Number 1372690

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 09/03/2022

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized with a blood glucose value of 400 mg/dl and ketone bodies as a result of a bent cannula, which prevented the delivery of insulin.At the time of reporting the event, the patient's blood glucose level was already down to 200 mg/dl, and ketones were no longer detectable.However, the patient was still in the hospital.The information regarding treatment at the hospital was not provided.

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.The material 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: 15406268
• MDR Text Key: 299767775
• Report Number: 3011393376-2022-02710
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1372690
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female