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

Catalog Number	08256292001
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Codes	Dizziness (2194); Loss of consciousness (2418)
Date of Event	10/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received the following results over a period of several hours during the incident day: 104 mg/dl, 120 mg/dl, 89 mg/dl, 125 mg/dl and 130 mg/dl.At an unknown time on that day, the patient was not feeling well, experienced symptoms like dizziness, and passed out.The patient´s wife and daughter called the paramedics who gave the patient an unknown amount of insulin as treatment.The patient was stabilized and not taken to the hospital.

• Brand Name: ACCU-CHEK ® GUIDE
• 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 46250 1025
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 23520106
• Report Number: 3011393376-2025-01076
• Device Sequence Number: 18568137
• Product Code: LFR
• UDI-Device Identifier: 00365702719101
• UDI-Public: 00365702719101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• 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): 12/09/2025

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: 02/16/2026
• Device Catalogue Number: 08256292001
• Device Lot Number: 105073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 106 KG