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

Catalog Number	08256292001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 479 mg/dl and 126 mg/dl.

• 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 -045
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 -102
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250--045
• MDR Report Key: 50897028
• Report Number: 3011393376-2026-00599
• Device Sequence Number: 20296694
• Product Code: LFR
• UDI-Device Identifier: 00365702719101
• UDI-Public: 00365702719101
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 08256292001
• Device Lot Number: 105852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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 Sex: Female
• Patient Weight: 107 LB