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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 400's mg/dl and 90's mg/dl.And then on a separate day the user tested again and received the following results within 15 minutes: 300's mg/dl and 90's mg/dl.The user could not recall the exact values for each set of comparisons.The user stated that the readings were obtained using the same vial of strips, lot.102981, and that the test strips were not expired at the time of the event.

• 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: 23758316
• Report Number: 3011393376-2025-01157
• Device Sequence Number: 13282882
• Product Code: LFR
• UDI-Device Identifier: 00365702719101
• UDI-Public: 00365702719101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/03/2026

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 Expiration Date: 06/16/2023
• Device Catalogue Number: 08256292001
• Device Lot Number: 102981
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2021
• 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: ALLOPURINOL; APIXABAN; BABY ASPIRIN; BLOOD PRESSURE CUFF; CPAP MACHINE; FINASTERIDE; FLUOXETINE; FUROSEMIDE; GABAPENTIN; LISINOPRIL; MEMANTINE; METFORMIN; POTASSIUM; TAMSULOSIN; VITAMIN B12; VITAMIN C; VITAMIN D3
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 91 KG