MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA COMBO; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 05151937005

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Hyperglycemia (1905)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that the bolus recommendations provided by the blood glucose monitor are not accurate.The patient measured a blood glucose value of 448 mg/dl at 09:58h and 429 mg/dl with active insulin of 1.3 insulin units at 11:19h and obtained a bolus advice of 2 insulin units.The patient questioned the correctness of the bolus recommendation and administrated 3 insulin units via the pen.No adverse event reported.

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.

• Brand Name: ACCU-CHEK ® AVIVA COMBO
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; 13000 south memorial parkway; na; huntsville AL 35807
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 17691158
• MDR Text Key: 322742447
• Report Number: 3011393376-2023-02024
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05151937005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Sex: Female