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

Catalog Number	05075637005
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bolus recommendations provided by the blood glucose monitor are not accurate.The patient received an estimated blood glucose result of 170 mg/dl around 6:30 a.M.And the bolus recommendation was 2.5 units of insulin based on the blood glucose result.The patient thought the recommendation was too much, but she delivered 3 units of humalog injection.The patient started to experience symptoms of disorientation associated with low blood glucose.She was able to consume food and drink on her own to increase the blood glucose level without outside assistance.The patient believed a 2.0 units recommendation would have been appropriate on the blood glucose monitor.
Additional Manufacturer Narrative
Correction - the catalog and unique identifier numbers were updated in section d4 based on the returned product.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on errors that occurred in the submission of mdrs for incorrect manufacturer name and/or address.A non-conformance report (ncr) ¿ 16847 to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• Brand Name: ACCU-CHEK ® AVIVA EXPERT
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA CORPORATION; 13000 south memorial parkway; na; huntsville AL 35803
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18915399
• Report Number: 3011393376-2024-00634
• Device Sequence Number: 12443319
• Product Code: NBW
• UDI-Device Identifier: 00365702641105
• UDI-Public: 00365702641105
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 05075637005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 07/22/2025
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/26/2024; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HUMALOG INSULIN
• Patient Age: 62 YR
• Patient Sex: Female