MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® SPIRIT COMBO; INSULIN INFUSION PUMP

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

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 10/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient was admitted to hospital with diabetic ketoacidosis with a blood glucose level above 500 mg/dl and abdominal pain.At the hospital, the patient was treated with insulin and medication (antibiotics).The patient also underwent an urgent ct scan, during which he did not remove the pump.The patient was discharged on (b)(6) 2022.The patient stopped using the insulin pump and administered insulin with an insulin pen.

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.Product is not expected to be returned.

• Brand Name: ACCU-CHEK ® SPIRIT COMBO
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 16497405
• MDR Text Key: 310818971
• Report Number: 3011393376-2023-00597
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/07/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male