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

Catalog Number	06908268001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's blood glucose level was over 200 mg/dl on (b)(6) /2025 at 8:30 p.M.The patient administered 1 unit of humalog insulin base on the blood glucose result.Around an hour later, at 9:30 p.M., a new reading showed her blood glucose had risen to 250 mg/dl.Believing the first dose was ineffective, she delivered an additional 0.5 units of humalog insulin.Around 10:30 p.M., she awoke to a blood glucose reading of 30 mg/dl.She was unable to self-treat and called her sister for help.The patient reported a panic attack and difficulty breathing before losing consciousness for an estimated 3 to 5 minutes.The patient's sister provided treatment with two to three grapes at around 10:30 p.M.Or 11:00 p.M.An attempt was made to call the paramedics, but the phone was not working.The patient was not taken to a medical facility.

• Brand Name: ACCU-CHEK ® AVIVA PLUS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 22677580
• Report Number: 3011393376-2025-00835
• Device Sequence Number: 9000406
• Product Code: LFR
• UDI-Device Identifier: 00365702408104
• UDI-Public: 00365702408104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 06908268001
• Device Lot Number: 690719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HUMALOG INSULIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 53 KG