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

Lot Number ASKU

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 05/21/2018

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 patient was hospitalized due to elevated blood glucose levels while wearing the infusion set.It was reported that the patient woke up in the morning with a blood glucose result of 500 mg/dl.The patient experienced elevated blood glucose symptoms of dehydration, feeling sick, and vomited.The patient went to the hospital.At the hospital, the patient was treated for high blood glucose, but the type of treatment given was unknown.The results from the hospital meter were also unknown.The patient stated the high blood glucose was caused because he accidentally slept all night with the transfer set bent, caused by the position of the body in the bed, that obstructed the insulin delivery.The patient was hospitalized for one day.The lot number was not provided.The infusion set was discarded; therefore, no product could be requested to be returned for product evaluation.

• 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: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7560872
• MDR Text Key: 109789859
• Report Number: 3011393376-2018-02269
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/01/2018

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 Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention